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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Skin Closure
510(k) Number K942526
Device Name SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM
Applicant
Life Medical Sciences, Inc.
214 Carnegie Center
Princeton,  NJ  08540
Applicant Contact GLENN A RAHMOELLER
Correspondent
Life Medical Sciences, Inc.
214 Carnegie Center
Princeton,  NJ  08540
Correspondent Contact GLENN A RAHMOELLER
Regulation Number878.4320
Classification Product Code
MKY  
Date Received05/27/1994
Decision Date 07/19/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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