FREE CHOICE

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 Free Choice.

Pre-market Notification Details

• Device ID: K963032
• 510k Number: K963032
• Device Name: FREE CHOICE
• 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: 1996-08-05
• Decision Date: 1996-10-11
• Summary: summary