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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cassette, Radiographic Film
510(k) Number K983918
Device Name RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP)
Applicant
Mastek, Inc.
1200 Binz, Suite 1200
Houston,  TX  77004
Applicant Contact MARCOS V MASSON
Correspondent
Mastek, Inc.
1200 Binz, Suite 1200
Houston,  TX  77004
Correspondent Contact MARCOS V MASSON
Regulation Number892.1850
Classification Product Code
IXA  
Date Received11/04/1998
Decision Date 03/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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