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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single-Use Reprocessed Ultrasonic Surgical Instruments
510(k) Number K100537
Device Name REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE
Applicant
Ascent Healthcare Solutions
10232 S. 51st St.
Phoenix,  AZ  85044
Applicant Contact RAMONA KULIK
Correspondent
Ascent Healthcare Solutions
10232 S. 51st St.
Phoenix,  AZ  85044
Correspondent Contact RAMONA KULIK
Classification Product Code
NLQ  
Date Received02/25/2010
Decision Date 05/12/2010
Decision Substantially Equivalent (SESE)
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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