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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 K936095
Device Name GAUZE SPONGE
Applicant
Dukal Corp.
P.O. Box 2308
1247 Florida Ave.
Palm Harbor,  FL  34682
Applicant Contact PATRICK J LAMB
Correspondent
Dukal Corp.
P.O. Box 2308
1247 Florida Ave.
Palm Harbor,  FL  34682
Correspondent Contact PATRICK J LAMB
Classification Product Code
EFQ  
Date Received12/22/1993
Decision Date 02/02/1994
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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