CHEST CATHETERS/THORACIC CATHETERS

Catheter, Ventricular, General & Plastic Surgery

MEDOVATIONS, INC.

The following data is part of a premarket notification filed by Medovations, Inc. with the FDA for Chest Catheters/thoracic Catheters.

Pre-market Notification Details

Device IDK851048
510k NumberK851048
Device Name:CHEST CATHETERS/THORACIC CATHETERS
ClassificationCatheter, Ventricular, General & Plastic Surgery
Applicant MEDOVATIONS, INC. 11311 WEST LOCUST ST. Wauwatosa,  WI  53222
ContactSury R Shoney
CorrespondentSury R Shoney
MEDOVATIONS, INC. 11311 WEST LOCUST ST. Wauwatosa,  WI  53222
Product CodeGBS  
CFR Regulation Number878.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-03-14
Decision Date1985-06-05

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