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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shield, Protective, Personnel
510(k) Number K934206
Device Name MAVIG ANGIO SHIELD MODELS 6290 & 6272
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
KPY  
Date Received08/30/1993
Decision Date 10/07/1993
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
Recalls CDRH Recalls
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