DISOPOSABLE & RESUABLE MONPOLAR CORD

Electrosurgical, Cutting & Coagulation & Accessories

BOSTON SURGICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Boston Surgical Products, Inc. with the FDA for Disoposable & Resuable Monpolar Cord.

Pre-market Notification Details

Device IDK951912
510k NumberK951912
Device Name:DISOPOSABLE & RESUABLE MONPOLAR CORD
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant BOSTON SURGICAL PRODUCTS, INC. 203 INDIAN POND RD. Kingston,  MA  02364
ContactLawrence T Kirwan, Jr.
CorrespondentLawrence T Kirwan, Jr.
BOSTON SURGICAL PRODUCTS, INC. 203 INDIAN POND RD. Kingston,  MA  02364
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-24
Decision Date1995-05-12

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