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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
510(k) Number K861142
Device Name MASTER KIT B
Applicant
Pro-Lab, Inc.
Post Office Box 11276
Birmingham,  AL  35201
Applicant Contact DAN MCDONALD
Correspondent
Pro-Lab, Inc.
Post Office Box 11276
Birmingham,  AL  35201
Correspondent Contact DAN MCDONALD
Regulation Number878.4800
Classification Product Code
LRP  
Date Received03/26/1986
Decision Date 07/10/1986
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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