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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, fluoroscopic, image-intensified
510(k) Number K850959
Device Name EQUIPMENT SNAP KOVERS
Applicant
ADVANCE MEDICAL DESIGNS, INC.
1400 MARIETTA PARKWAY, SU 105
MARIETTA,  GA  30067
Applicant Contact JOSEPH R COTTONE
Correspondent
ADVANCE MEDICAL DESIGNS, INC.
1400 MARIETTA PARKWAY, SU 105
MARIETTA,  GA  30067
Correspondent Contact JOSEPH R COTTONE
Regulation Number892.1650
Classification Product Code
JAA  
Date Received03/08/1985
Decision Date 04/09/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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