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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name table, surgical with orthopedic accessories, manual
510(k) Number K905816
Device Name ORTHOVISION TABLE
Applicant
AMERICAN STERILIZER CO.
2424 WEST 23RD ST.
P.O. BOX 620
ERIE,  PA  16514
Applicant Contact MICHAEL J ZMUDA
Correspondent
AMERICAN STERILIZER CO.
2424 WEST 23RD ST.
P.O. BOX 620
ERIE,  PA  16514
Correspondent Contact MICHAEL J ZMUDA
Regulation Number878.4950
Classification Product Code
JEB  
Date Received12/28/1990
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
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