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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Patient Position, Light-Beam
510(k) Number K872894
Device Name A2J MZ 44 LASER LIGHT FOR POSITIONING
Applicant
Prometex, Inc.
10500 Richmond Suite 201
Houston,  TX  77042
Applicant Contact M BUTTERLIN
Correspondent
Prometex, Inc.
10500 Richmond Suite 201
Houston,  TX  77042
Correspondent Contact M BUTTERLIN
Regulation Number892.5780
Classification Product Code
IWE  
Date Received07/23/1987
Decision Date 08/12/1987
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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