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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Ultrasonic, Nonfetal
510(k) Number K943200
Device Name FLOSCOPE SUPER VASCULAR LAB
Applicant
Advance Medical Device, Inc.
P. O. Box 1419
Camden,  NJ  08105
Applicant Contact DAVID LERNER
Correspondent
Advance Medical Device, Inc.
P. O. Box 1419
Camden,  NJ  08105
Correspondent Contact DAVID LERNER
Regulation Number892.1540
Classification Product Code
JAF  
Date Received07/05/1994
Decision Date 11/21/1995
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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