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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 K894610
Device Name CUSTOM TRAYS, KITS
Applicant
L H M Ent., Inc.
855 Virginia Ave.,
P.O. Box 431
Palm Harbor,  FL  34683
Applicant Contact PATRICK J LAMB
Correspondent
L H M Ent., Inc.
855 Virginia Ave.,
P.O. Box 431
Palm Harbor,  FL  34683
Correspondent Contact PATRICK J LAMB
Regulation Number878.4800
Classification Product Code
FSM  
Date Received07/20/1989
Decision Date 03/15/1990
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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