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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal
510(k) Number K810200
Device Name OPTIPORE SCRUB SPONGE
Applicant
Bio Syntec
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Bio Syntec
4221 Richmond Rd., NW
Walker,  MI  49534
Classification Product Code
EFQ  
Date Received01/23/1981
Decision Date 02/13/1981
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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