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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K843525
Device Name SUTURE TRAY
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
Date Received09/07/1984
Decision Date 11/05/1984
Decision Substantially Equivalent (SESE)
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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