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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Punch, Surgical
510(k) Number K904869
Device Name ELLIPSE PUNCH
Applicant
Kramer Const
819 University Avenure
Palo Alto,  CA  94301
Applicant Contact JESSE KRAMER
Correspondent
Kramer Const
819 University Avenure
Palo Alto,  CA  94301
Correspondent Contact JESSE KRAMER
Regulation Number878.4800
Classification Product Code
LRY  
Date Received10/29/1990
Decision Date 03/06/1991
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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