PK AIM

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 Aim.

Pre-market Notification Details

Device IDK163373
510k NumberK163373
Device Name:PK AIM
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Gyrus ACMI Inc. 136 Turnpike Road Southborough,  MA  01772
ContactGraham A.l. Baillie
CorrespondentGraham A.l. Baillie
Gyrus ACMI Inc. 136 Turnpike Road Southborough,  MA  01772
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-01
Decision Date2016-12-12
Summary:summary

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