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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Bone Growth, Non-Invasive
510(k) Number K822155
Device Name ETHICON TEMPORARY CARDIAC PACING WIRE
Applicant
Ethicon, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Ethicon, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Classification Product Code
LOF  
Date Received07/23/1982
Decision Date 08/24/1982
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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