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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 K955321
Device Name PROTEC GAUZE SPONGE
Applicant
Derivados DE Gasa, S.A. DE C.V.
1247 Florida Ave.
Palm Harobor,  FL  34683
Applicant Contact PATRICK J LAMB
Correspondent
Derivados DE Gasa, S.A. DE C.V.
1247 Florida Ave.
Palm Harobor,  FL  34683
Correspondent Contact PATRICK J LAMB
Classification Product Code
EFQ  
Date Received11/20/1995
Decision Date 12/19/1995
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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