Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000; Class II

Reason: Product lacks 510(k) clearance.

DAYE (ANNE'S DAY LTD) 20250217 Ongoing
Distributed: US Nationwide distribution.
Initiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000; Class II

Reason: Product lacks 510(k) clearance.

DAYE (ANNE'S DAY LTD) 20250217 Ongoing
Distributed: US Nationwide distribution.
Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF; Class II

Reason: Product lacks 510(k) clearance.

DAYE (ANNE'S DAY LTD) 20250217 Ongoing
Distributed: US Nationwide distribution.
Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF; Class II

Reason: Product lacks 510(k) clearance.

DAYE (ANNE'S DAY LTD) 20250217 Ongoing
Distributed: US Nationwide distribution.
Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO; Class II

Reason: Product lacks 510(k) clearance.

DAYE (ANNE'S DAY LTD) 20250217 Ongoing
Distributed: US Nationwide distribution.
Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909; Class II

Reason: Product lacks 510(k) clearance.

DAYE (ANNE'S DAY LTD) 20250217 Ongoing
Distributed: US Nationwide distribution.
Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018; Class II

Reason: Product lacks 510(k) clearance.

DAYE (ANNE'S DAY LTD) 20250217 Ongoing
Distributed: US Nationwide distribution.
Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800; Class II

Reason: Product lacks 510(k) clearance.

DAYE (ANNE'S DAY LTD) 20250217 Ongoing
Distributed: US Nationwide distribution.
Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-REF18180000; Class II

Reason: Product lacks 510(k) clearance.

DAYE (ANNE'S DAY LTD) 20250217 Ongoing
Distributed: US Nationwide distribution.
Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000; Class II

Reason: Product lacks 510(k) clearance.

DAYE (ANNE'S DAY LTD) 20250217 Ongoing
Distributed: US Nationwide distribution.
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