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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Blood-Flow, Extravascular
510(k) Number K910441
Device Name FLOSCOPE MICRODOP
Applicant
Advance Medical Device, Inc.
P.O. Box 409
Berlin,  NJ  08009
Applicant Contact DAVID LERNER
Correspondent
Advance Medical Device, Inc.
P.O. Box 409
Berlin,  NJ  08009
Correspondent Contact DAVID LERNER
Regulation Number870.2120
Classification Product Code
DPT  
Date Received01/31/1991
Decision Date 03/21/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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