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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 K941649
Device Name SURGICAL SPONGE
Applicant
Industries For the Blind & Visually Impaired
206 W. First St.
Delhi,  LA  71232
Applicant Contact GEORGE PAYNE
Correspondent
Industries For the Blind & Visually Impaired
206 W. First St.
Delhi,  LA  71232
Correspondent Contact GEORGE PAYNE
Classification Product Code
EFQ  
Date Received04/05/1994
Decision Date 06/03/1994
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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