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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 K970455
Device Name DUKAL NON ADHERENT DRESSING
Applicant
Dukal Corp.
40178 U.S. 19 N.
Tarpon Springs,  FL  34689
Applicant Contact PATRICK LAMB
Correspondent
Dukal Corp.
40178 U.S. 19 N.
Tarpon Springs,  FL  34689
Correspondent Contact PATRICK LAMB
Classification Product Code
EFQ  
Date Received02/06/1997
Decision Date 05/08/1997
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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