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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name table and attachments, operating-room
510(k) Number K792569
Device Name OPERATING TABLES & AMPLINOX 03
Applicant
ETS RENE MARZET
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ETS RENE MARZET
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4950
Classification Product Code
BWN  
Date Received12/13/1979
Decision Date 01/04/1980
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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