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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Curtain, Protective, Radiographic
510(k) Number K945238
Device Name MAVIG LOWER BODY PROTECTION SYSTEMS, ASSEMBLY MODELS 6265, 6266, 6267, 6268, 6269/0, 629/1, AND 6269/2
Applicant
F. Walter Hanel GmbH
49 Plain St.
N. Attleboro,  MA  02760 -4153
Applicant Contact MARY M MCNAMARA
Correspondent
F. Walter Hanel GmbH
49 Plain St.
N. Attleboro,  MA  02760 -4153
Correspondent Contact MARY M MCNAMARA
Regulation Number892.6500
Classification Product Code
IWQ  
Date Received10/27/1994
Decision Date 12/15/1994
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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