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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Barrier, Control Panel, X-Ray, Movable
510(k) Number K881591
Device Name A2J MZ 45 LASER LIGHT FOR POSITIONING
Applicant
A2j, Inc.
10500 Richmond Suite 201
Houston,  TX  77042
Applicant Contact ZIMMER
Correspondent
A2j, Inc.
10500 Richmond Suite 201
Houston,  TX  77042
Correspondent Contact ZIMMER
Regulation Number892.6500
Classification Product Code
IWX  
Date Received04/13/1988
Decision Date 04/27/1988
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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