AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER

Electrosurgical, Cutting & Coagulation & Accessories

SALIENT SURGICAL TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Salient Surgical Technologies, Inc. with the FDA for Aquamantys Sbs 5.0 Sheated Biopolar Sealer.

Pre-market Notification Details

Device IDK111732
510k NumberK111732
Device Name:AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant SALIENT SURGICAL TECHNOLOGIES, INC. 180 INTERNATIONAL DRIVE Portsmouth,  NH  03801
ContactMartin J Leighton
CorrespondentMartin J Leighton
SALIENT SURGICAL TECHNOLOGIES, INC. 180 INTERNATIONAL DRIVE Portsmouth,  NH  03801
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-20
Decision Date2011-12-05
Summary:summary

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