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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
510(k) Number K092684
Device Name LAPAROSCOPIC RETRACTORS
Applicant
CARDINAL HEALTH, INC.
1430 WAUKEGAN ROAD- MPKB-3B
MCGAW PARK,  IL  60085
Applicant Contact SHARON NICHOLS
Correspondent
CARDINAL HEALTH, INC.
1430 WAUKEGAN ROAD- MPKB-3B
MCGAW PARK,  IL  60085
Correspondent Contact SHARON NICHOLS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/01/2009
Decision Date 01/22/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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