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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 K003587
Device Name CLEARGLIDE PRECISION BIPOLAR DEVICE
Applicant
Ethicon, Inc.
Route 22 W. P.O. Box 151
Somerville,  NJ  08876 -0151
Applicant Contact GREGORY R JONES
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/21/2000
Decision Date 12/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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