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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dissector, Surgical, General & Plastic Surgery
510(k) Number K896383
Device Name DISPOSABLE EXTERNAL CLAMPS
Applicant
Galenica Enterprises, Inc.
C.P. 13
Ste-Therese
Quebec Canada J7e 4h7,  CA
Applicant Contact BETTY MAILHOT
Correspondent
Galenica Enterprises, Inc.
C.P. 13
Ste-Therese
Quebec Canada J7e 4h7,  CA
Correspondent Contact BETTY MAILHOT
Regulation Number878.4800
Classification Product Code
GDI  
Date Received11/06/1989
Decision Date 12/06/1989
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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