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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K931844
Device Name CUSTOM PROCEDURE MEDICAL TRAY OR KIT
Applicant
Custom Medical Products, Ltd.
P.O. Box 8875
Asheville,  NC  28814
Applicant Contact ALLEN B MORLOCK
Correspondent
Custom Medical Products, Ltd.
P.O. Box 8875
Asheville,  NC  28814
Correspondent Contact ALLEN B MORLOCK
Regulation Number878.4370
Classification Product Code
LRO  
Date Received04/13/1993
Decision Date 01/25/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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