BIPOLAR 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 Bipolar Cord.

Pre-market Notification Details

Device IDK944578
510k NumberK944578
Device Name:BIPOLAR 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 Received1994-09-19
Decision Date1994-12-08

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