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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 K110257
Device Name DIAMOND-FLEX(R) GRASPERS
Applicant
CAREFUSION 2200, INC.
1500 WAUKEGAN ROAD
MCGAW PARK,  IL  60085
Applicant Contact JANE WEBER
Correspondent
CAREFUSION 2200, INC.
1500 WAUKEGAN ROAD
MCGAW PARK,  IL  60085
Correspondent Contact JANE WEBER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/28/2011
Decision Date 05/06/2011
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
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