AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K111732
Device Name AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER
Applicant
SALIENT SURGICAL TECHNOLOGIES, INC.
180 international drive
portsmouth, 
NH 
03801

Applicant Contact martin j leighton
Correspondent
SALIENT SURGICAL TECHNOLOGIES, INC.
180 international drive
portsmouth, 
NH 
03801

Correspodent Contact martin j leighton
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 06/20/2011
Decision Date 12/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No