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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Selective And Differential
510(k) Number K872058
Device Name ORICULT-N 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 Number866.2360
Classification Product Code
JSI  
Date Received05/28/1987
Decision Date 06/10/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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