GELBFISH ENDO-VAC SYSTEM

Catheter, Peripheral, Atherectomy

GARY A. GELBFISH

The following data is part of a premarket notification filed by Gary A. Gelbfish with the FDA for Gelbfish Endo-vac System.

Pre-market Notification Details

Device IDK970233
510k NumberK970233
Device Name:GELBFISH ENDO-VAC SYSTEM
ClassificationCatheter, Peripheral, Atherectomy
Applicant GARY A. GELBFISH 12300 TWINBROOK PKWY. SUITE 625 Rockville,  MD  20852
ContactRobert L Sheridan
CorrespondentRobert L Sheridan
GARY A. GELBFISH 12300 TWINBROOK PKWY. SUITE 625 Rockville,  MD  20852
Product CodeMCW  
CFR Regulation Number870.4875 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-01-21
Decision Date1997-10-08
Summary:summary

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