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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact RITA M CALNAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/06/2011
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
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