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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 Pkwy., Su 105
Marietta,  GA  30067
Applicant Contact JOSEPH R COTTONE
Correspondent
Advance Medical Designs, Inc.
1400 Marietta Pkwy., 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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