MODEL 50 BIPOLAR COAGULATOR

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 Model 50 Bipolar Coagulator.

Pre-market Notification Details

Device IDK972350
510k NumberK972350
Device Name:MODEL 50 BIPOLAR COAGULATOR
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant BOSTON SURGICAL PRODUCTS, INC. 17 OLD COUNTRY RD. Oxford,  CT  06478 -1715
ContactCharles Vassallo
CorrespondentCharles Vassallo
BOSTON SURGICAL PRODUCTS, INC. 17 OLD COUNTRY RD. Oxford,  CT  06478 -1715
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-24
Decision Date1997-08-21
Summary:summary

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