OPTIPORE SCRUB SPONGE

Gauze/sponge, Internal

BIO SYNTEC

The following data is part of a premarket notification filed by Bio Syntec with the FDA for Optipore Scrub Sponge.

Pre-market Notification Details

• Device ID: K810200
• 510k Number: K810200
• Device Name: OPTIPORE SCRUB SPONGE
• Classification: Gauze/sponge, Internal
• Applicant: BIO SYNTEC 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: EFQ
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-01-23
• Decision Date: 1981-02-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00768455108107	K810200	000