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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 K880911
Device Name BLUNT SPONGE
Applicant
Ormed Mfg., Inc.
175 Great Arrow Ave.
Buffalo,  NY  14207
Applicant Contact ANN M JOHNSON
Correspondent
Ormed Mfg., Inc.
175 Great Arrow Ave.
Buffalo,  NY  14207
Correspondent Contact ANN M JOHNSON
Classification Product Code
EFQ  
Date Received03/03/1988
Decision Date 03/17/1988
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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