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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 K823772
Device Name AMSCO ORTHOGRAPHIC 2 TABLE
Applicant
AMERICAN STERILIZER CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AMERICAN STERILIZER CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4950
Classification Product Code
BWN  
Date Received12/14/1982
Decision Date 01/14/1983
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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