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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Surgical, General Use
510(k) Number K942896
Device Name CLAMPS AND CLIPS
Applicant
Surgin Surgical Instrumentation, Inc.
14762 Bentley Circle
Tustin,  CA  92680
Applicant Contact DON W HAAR
Correspondent
Surgin Surgical Instrumentation, Inc.
14762 Bentley Circle
Tustin,  CA  92680
Correspondent Contact DON W HAAR
Regulation Number878.4800
Classification Product Code
MDM  
Date Received06/20/1994
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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