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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vacuum Sample, With Anticoagulant
510(k) Number K791200
Device Name PRE-DENT
Applicant
Fichte, Graves, and Hunt
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Fichte, Graves, and Hunt
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1675
Classification Product Code
GIM  
Date Received06/28/1979
Decision Date 08/10/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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