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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
510(k) Number K944590
Device Name ETHICON DRILL BIT AND DRILL GUIDE
Applicant
ETHICON, Inc.
P.O Box 151, Rte. 22 W.
Somerville,  NJ  08876
Applicant Contact JOHN D PAULSON
Correspondent
ETHICON, Inc.
P.O Box 151, Rte. 22 W.
Somerville,  NJ  08876
Correspondent Contact JOHN D PAULSON
Regulation Number878.4820
Classification Product Code
HSZ  
Subsequent Product Code
HWE  
Date Received09/19/1994
Decision Date 05/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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