GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AND DUAL FOOTSWITCH CONNECTOR CABLE, MODEL 710003

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 Gyrus Acmi Plasmakinetic (pk) Superpulse System, Model 744000 And Dual Footswitch Connector Cable, Model 710003.

Pre-market Notification Details

Device IDK082054
510k NumberK082054
Device Name:GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AND DUAL FOOTSWITCH CONNECTOR CABLE, MODEL 710003
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough,  MA  01772
ContactTerrence E Sullivan
CorrespondentTerrence E Sullivan
GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough,  MA  01772
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-07-21
Decision Date2008-08-06
Summary:summary

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