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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery, Reprocessed
510(k) Number K063788
Device Name REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS
Applicant
Ascent Healthcare Solutions
10232 S. 51st St.
Phoenix,  AZ  85044
Applicant Contact KATIE BRAY
Correspondent
Ascent Healthcare Solutions
10232 S. 51st St.
Phoenix,  AZ  85044
Correspondent Contact KATIE BRAY
Regulation Number876.1500
Classification Product Code
NLM  
Date Received12/21/2006
Decision Date 10/15/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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