THOROCENTESIS KIT

Catheter And Tip, Suction

MEGADYNE MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Thorocentesis Kit.

Pre-market Notification Details

Device IDK910963
510k NumberK910963
Device Name:THOROCENTESIS KIT
ClassificationCatheter And Tip, Suction
Applicant MEGADYNE MEDICAL PRODUCTS, INC. 400 OSER AVE. Hauppauge,  NY  11788
ContactEllen Joy
CorrespondentEllen Joy
MEGADYNE MEDICAL PRODUCTS, INC. 400 OSER AVE. Hauppauge,  NY  11788
Product CodeJOL  
CFR Regulation Number880.6740 [🔎]
DecisionSubstantially Equivalent - Kit With Drugs (SEKD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-06
Decision Date1991-06-20

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