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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Surgical Instrument, Pneumatic Powered
510(k) Number K885066
Device Name HEMATOME SYSTEM
Applicant
Surgical Dynamics, Inc.
650 Whitney St.
San Leandro,  CA  94577
Applicant Contact RONALD ALLEN
Correspondent
Surgical Dynamics, Inc.
650 Whitney St.
San Leandro,  CA  94577
Correspondent Contact RONALD ALLEN
Regulation Number878.4820
Classification Product Code
GET  
Date Received12/06/1988
Decision Date 05/01/1989
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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