MEGA LACERATION KIT

General Surgery Tray

MEGADYNE MEDICAL PRODUCTS, INC.

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

Pre-market Notification Details

Device IDK910368
510k NumberK910368
Device Name:MEGA LACERATION KIT
ClassificationGeneral Surgery Tray
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 CodeLRO  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-01-29
Decision Date1991-03-18

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