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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 K111732
Device Name AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER
Applicant
Salient Surgical Technologies, Inc.
180 International Dr.
Portsmouth,  NH  03801
Applicant Contact MARTIN J LEIGHTON
Correspondent
Salient Surgical Technologies, Inc.
180 International Dr.
Portsmouth,  NH  03801
Correspondent Contact MARTIN J LEIGHTON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/20/2011
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
Predetermined Change
Control Plan Authorized		 No
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