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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 K163615
Device Name Snowden-Pencer MicroLap 3mm Laparoscopic Instruments
Applicant
Carefusion 2200, Inc.
75 N Fairway Dr.
Vernon Hills,  IL  60061
Applicant Contact Jane Weber
Correspondent
Carefusion 2200, Inc.
75 N Fairway Dr.
Vernon Hills,  IL  60061
Correspondent Contact Jane Weber
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
GCJ  
Date Received12/22/2016
Decision Date 05/04/2017
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
Predetermined Change
Control Plan Authorized		 No
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