PK J-HOOK

Electrosurgical, Cutting & Coagulation & Accessories

GYRUS ACMI INC.

The following data is part of a premarket notification filed by Gyrus Acmi Inc. with the FDA for Pk J-hook.

Pre-market Notification Details

Device IDK142350
510k NumberK142350
Device Name:PK J-HOOK
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant GYRUS ACMI INC. 136 TURNPIKE ROAD Southborough,  MA  01772
ContactNeil Kelly
CorrespondentNeil Kelly
GYRUS ACMI INC. 136 TURNPIKE ROAD Southborough,  MA  01772
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-22
Decision Date2015-01-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821925028128 K142350 000

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