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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter (Beta, Gamma) For Clinical Use
510(k) Number K851164
Device Name DENTOCULT CULTURE-PADDLE
Applicant
Orion Corp.
P.O. Box 425
20101 Turku,  FI
Applicant Contact TIMO RAINES
Correspondent
Orion Corp.
P.O. Box 425
20101 Turku,  FI
Correspondent Contact TIMO RAINES
Regulation Number862.2320
Classification Product Code
JJJ  
Date Received03/22/1985
Decision Date 10/29/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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