Refill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000; Class II

Reason: Product lacks 510(k) clearance.

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

Reason: Product lacks 510(k) clearance.

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

Reason: Product lacks 510(k) clearance.

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

Reason: Product lacks 510(k) clearance.

DAYE (ANNE'S DAY LTD) 20250217 Ongoing
Distributed: US Nationwide distribution.
Trial Tampon Box; Model Number: FG-TMP-REF04050504; Class II

Reason: Product lacks 510(k) clearance.

DAYE (ANNE'S DAY LTD) 20250217 Ongoing
Distributed: US Nationwide distribution.
9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009; Class II

Reason: Product lacks 510(k) clearance.

DAYE (ANNE'S DAY LTD) 20250217 Ongoing
Distributed: US Nationwide distribution.
9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900; Class II

Reason: Product lacks 510(k) clearance.

DAYE (ANNE'S DAY LTD) 20250217 Ongoing
Distributed: US Nationwide distribution.
9 Coated Regular and 9 Coated Super Tampons; Model Number: FG-TMP-REF09090000; Class II

Reason: Product lacks 510(k) clearance.

DAYE (ANNE'S DAY LTD) 20250217 Ongoing
Distributed: US Nationwide distribution.
18 Coated Super Tampons; Model Number: FG-TMP-REF00180000; Class II

Reason: Product lacks 510(k) clearance.

DAYE (ANNE'S DAY LTD) 20250217 Ongoing
Distributed: US Nationwide distribution.
18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000; Class II

Reason: Product lacks 510(k) clearance.

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