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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K113407
Device Name SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORS
Applicant
CAREFUSION 2200, INC.
1500 WAUKEGAN ROAD
MCGAW PARK,  IL  60085
Applicant Contact KATE FULLER
Correspondent
CAREFUSION 2200, INC.
1500 WAUKEGAN ROAD
MCGAW PARK,  IL  60085
Correspondent Contact KATE FULLER
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
HET  
Date Received11/18/2011
Decision Date 09/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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