PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE

Electrosurgical, Cutting & Coagulation & Accessories

PEAK SURGICAL, INC.

The following data is part of a premarket notification filed by Peak Surgical, Inc. with the FDA for Peak Plasmablade Tna Tonsil And Adenoid Tissue Dissection Device.

Pre-market Notification Details

Device IDK083415
510k NumberK083415
Device Name:PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant PEAK SURGICAL, INC. 2464 EMBARCADERO WAY Palo Alto,  CA  94303
ContactLois Nakayama
CorrespondentLois Nakayama
PEAK SURGICAL, INC. 2464 EMBARCADERO WAY Palo Alto,  CA  94303
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-11-18
Decision Date2009-06-05
Summary:summary

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