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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Surgical, Instrument
510(k) Number K844652
Device Name C.A.S.E. CONTAINER
Applicant
GENERAL MEDICAL CO.
1575 EYE ST. NW
WASHINGTON,  DC  20005
Applicant Contact DANIEL J MANELLI
Correspondent
GENERAL MEDICAL CO.
1575 EYE ST. NW
WASHINGTON,  DC  20005
Correspondent Contact DANIEL J MANELLI
Regulation Number878.4800
Classification Product Code
FSM  
Date Received11/29/1984
Decision Date 12/12/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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