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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Strip, Adhesive, Closure, Skin
510(k) Number K931005
Device Name DUKAL SKIN CLOSURE STRIP
Applicant
Dukal Corp.
17 Crossway
Clinton,  NJ  08809
Applicant Contact JOEL CADEMARTORI
Correspondent
Dukal Corp.
17 Crossway
Clinton,  NJ  08809
Correspondent Contact JOEL CADEMARTORI
Regulation Number880.5240
Classification Product Code
FPX  
Date Received02/26/1993
Decision Date 07/14/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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