TELESCOPING PENEVAC

Electrosurgical, Cutting & Coagulation & Accessories

I.C. MEDICAL, INC.

The following data is part of a premarket notification filed by I.c. Medical, Inc. with the FDA for Telescoping Penevac.

Pre-market Notification Details

Device IDK954088
510k NumberK954088
Device Name:TELESCOPING PENEVAC
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant I.C. MEDICAL, INC. 5170 PHELPS RD. SUITE D Glendale,  AZ  85306
ContactKurt Hasper
CorrespondentKurt Hasper
I.C. MEDICAL, INC. 5170 PHELPS RD. SUITE D Glendale,  AZ  85306
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-31
Decision Date1995-09-22

NIH GUDID Devices

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