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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 K920292
Device Name VARIOUS KITS AND TRAYS
Applicant
Professional Medical Products, Inc.
1909 NE 25th Ave.
Ocala,  FL  32670
Applicant Contact R. L CUTRIGHT
Correspondent
Professional Medical Products, Inc.
1909 NE 25th Ave.
Ocala,  FL  32670
Correspondent Contact R. L CUTRIGHT
Regulation Number878.4370
Classification Product Code
LRO  
Date Received01/22/1992
Decision Date 01/26/1994
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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