FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS

Tampon, Menstrual, Unscented

FIRST QUALITY HYGIENIC, INC.

The following data is part of a premarket notification filed by First Quality Hygienic, Inc. with the FDA for Femtex Junior/slender Regular Open-end Tampons.

Pre-market Notification Details

• Device ID: K031067
• 510k Number: K031067
• Device Name: FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS
• Classification: Tampon, Menstrual, Unscented
• Applicant: FIRST QUALITY HYGIENIC, INC. 73 FRANKLIN TURNPIKE Allendale, NJ 07401
• Contact: Robert J Staab
• Correspondent: Robert J Staab; FIRST QUALITY HYGIENIC, INC. 73 FRANKLIN TURNPIKE Allendale, NJ 07401
• Product Code: HEB
• CFR Regulation Number: 884.5470 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-04-04
• Decision Date: 2003-07-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B34025160273	K031067	000
10729661269454	K031067	000
10729661269447	K031067	000
10729661269348	K031067	000