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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Surgical Instrument, Disposable
510(k) Number K864969
Device Name JMS HALO APPLICATION TRAY
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 Number878.4800
Classification Product Code
KDD  
Date Received12/22/1986
Decision Date 02/18/1987
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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