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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, Ac-Powered
510(k) Number K882654
Device Name PHYSIOTRON(TM) MICROSURGICAL MOTOR & COOLING SYS.
Applicant
Surgical Innovators of America, Inc.
19 W. 34th St., Suite 301
New York,  NY  10001
Applicant Contact HOWARD KLIFF
Correspondent
Surgical Innovators of America, Inc.
19 W. 34th St., Suite 301
New York,  NY  10001
Correspondent Contact HOWARD KLIFF
Regulation Number878.4820
Classification Product Code
GEY  
Date Received06/29/1988
Decision Date 09/20/1988
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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