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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 K100080
Device Name REPROCESSED TROCARS, MODEL B5LT AND CB5LT
Applicant
ASCENT HEALTHCARE SOLUTIONS
10232 SOUTH 51ST ST.
PHOENIX,  AZ  85044
Applicant Contact MOIRA BARTON-VARTY
Correspondent
ASCENT HEALTHCARE SOLUTIONS
10232 SOUTH 51ST ST.
PHOENIX,  AZ  85044
Correspondent Contact MOIRA BARTON-VARTY
Regulation Number876.1500
Classification Product Code
NLM  
Date Received01/12/2010
Decision Date 03/19/2010
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
Recalls CDRH Recalls
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