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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
510(k) Number K984361
Device Name ORAL-EZE ORAL FLUID COLLECTION SYSTEM
Applicant
Osborn Laboratories, Inc.
14901 W. 117 St.
Olathe,  KS  66062
Applicant Contact GILBERT P BOURK III
Correspondent
Osborn Laboratories, Inc.
14901 W. 117 St.
Olathe,  KS  66062
Correspondent Contact GILBERT P BOURK III
Regulation Number862.1675
Classification Product Code
PJD  
Date Received12/07/1998
Decision Date 01/13/1999
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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