AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K111285
Device Name AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING
Applicant
SALIENT SURGICAL TECHNOLOGIES, INC.
180 international drive
portsmouth, 
NH 
03801

Applicant Contact rita m calnan
Correspondent
SALIENT SURGICAL TECHNOLOGIES, INC.
180 international drive
portsmouth, 
NH 
03801

Correspodent Contact rita m calnan
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 05/06/2011
Decision Date 09/09/2011
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

Recalls CDRH Recalls