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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 K861785
Device Name FLUOROSCOPE BAND BAG
Applicant
Medi-Plast Intl., Inc.
8601 Dunwoody Pl., NE
Suite 330
Atlanta,  GA  30338
Applicant Contact KATHLEEN A LUMBERG
Correspondent
Medi-Plast Intl., Inc.
8601 Dunwoody Pl., NE
Suite 330
Atlanta,  GA  30338
Correspondent Contact KATHLEEN A LUMBERG
Regulation Number892.1650
Classification Product Code
JAA  
Date Received05/08/1986
Decision Date 06/13/1986
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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