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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerclage, Fixation
510(k) Number K193479
Device Name Sternal Cable System
Applicant
A & E Medical Corporation
5206 Asbury Rd., P.O. Box 758
Farmingdale,  NJ  07727
Applicant Contact Peter Browne
Correspondent
A & E Medical Corporation
5206 Asbury Rd., P.O. Box 758
Farmingdale,  NJ  07727
Correspondent Contact Peter Browne
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received12/16/2019
Decision Date 03/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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