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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K993787
Device Name APPRAISE-CARDIO SAMPLE COLLECTION KIT
Applicant
Osborn Group, Inc.
14901 W. 117th St.
Olathe,  KS  66062
Applicant Contact GILBERT P BOURK III
Correspondent
Osborn Group, Inc.
14901 W. 117th St.
Olathe,  KS  66062
Correspondent Contact GILBERT P BOURK III
Regulation Number862.1675
Classification Product Code
JKA  
Date Received11/09/1999
Decision Date 04/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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