TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U

Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

HOBBS MEDICAL, INC.

The following data is part of a premarket notification filed by Hobbs Medical, Inc. with the FDA for Touchsoft Coagulator With Banana Fitting, Model 4581 And With Universal Fitting, Model 4581-u.

Pre-market Notification Details

Device IDK093079
510k NumberK093079
Device Name:TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U
ClassificationUnit, Electrosurgical, Endoscopic (with Or Without Accessories)
Applicant HOBBS MEDICAL, INC. 8 SPRING ST. Stafford Springs,  CT  06076
ContactEmily Madsen
CorrespondentEmily Madsen
HOBBS MEDICAL, INC. 8 SPRING ST. Stafford Springs,  CT  06076
Product CodeKNS  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-30
Decision Date2010-08-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M849G11200400 K093079 000

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