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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 K843627
Device Name VENESECTION TRAY, ADULT 6050
Applicant
PRO-LAB, INC.
P.O. BOX 503
ROUND ROCK,  TX  78664
Applicant Contact DAN MCDONALD
Correspondent
PRO-LAB, INC.
P.O. BOX 503
ROUND ROCK,  TX  78664
Correspondent Contact DAN MCDONALD
Regulation Number878.4800
Classification Product Code
FSM  
Date Received09/14/1984
Decision Date 12/04/1984
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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