FLOSCOPE VASCULAR LAB.

Transducer, Ultrasonic

ADVANCE MEDICAL DEVICE, INC.

The following data is part of a premarket notification filed by Advance Medical Device, Inc. with the FDA for Floscope Vascular Lab..

Pre-market Notification Details

Device IDK905157
510k NumberK905157
Device Name:FLOSCOPE VASCULAR LAB.
ClassificationTransducer, Ultrasonic
Applicant ADVANCE MEDICAL DEVICE, INC. 2733 SAUNDERS ST. P.O. BOX 1419 Camden,  NJ  08105
ContactDavid Lerner
CorrespondentDavid Lerner
ADVANCE MEDICAL DEVICE, INC. 2733 SAUNDERS ST. P.O. BOX 1419 Camden,  NJ  08105
Product CodeJOP  
CFR Regulation Number870.2880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-11-16
Decision Date1991-03-15

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