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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrench
510(k) Number K870053
Device Name TORQUEDRIVER WRENCH
Applicant
Jerome Medical
102 Gaither Dr.
Mt Laurel,  NJ  08054
Applicant Contact SUZANNE B BEACHER
Correspondent
Jerome Medical
102 Gaither Dr.
Mt Laurel,  NJ  08054
Correspondent Contact SUZANNE B BEACHER
Regulation Number888.4540
Classification Product Code
HXC  
Date Received01/07/1987
Decision Date 03/11/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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