VASCUCLEAR PRECISION BIPOLAR

Electrosurgical, Cutting & Coagulation & Accessories

SORIN GROUP USA, INC.

The following data is part of a premarket notification filed by Sorin Group Usa, Inc. with the FDA for Vascuclear Precision Bipolar.

Pre-market Notification Details

Device IDK102983
510k NumberK102983
Device Name:VASCUCLEAR PRECISION BIPOLAR
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant SORIN GROUP USA, INC. 14401 WEST 65TH WAY Arvada,  CO  80004
ContactScott Light
CorrespondentScott Light
SORIN GROUP USA, INC. 14401 WEST 65TH WAY Arvada,  CO  80004
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-10-07
Decision Date2010-11-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10803622132459 K102983 000

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