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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Grid, Radiographic
510(k) Number K837776
Device Name AOR X-RAY ALIGMENT PAD
Applicant
Zimmer, Inc.
727 N. Detroit St.
Warsaw,  IN  46580
Correspondent
Zimmer, Inc.
727 N. Detroit St.
Warsaw,  IN  46580
Regulation Number892.1910
Classification Product Code
IXJ  
Date Received01/01/1983
Decision Date 08/18/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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