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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K850246
Device Name MASTER KIT A
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
Date Received01/22/1985
Decision Date 04/09/1985
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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