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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wax, Dental, Intraoral
510(k) Number K914892
Device Name SALIVA-STIM
Applicant
Orion Diagnostica, Inc.
P.O. Box 83
02101 Espoo,  FI
Applicant Contact TIMO RAINES
Correspondent
Orion Diagnostica, Inc.
P.O. Box 83
02101 Espoo,  FI
Correspondent Contact TIMO RAINES
Regulation Number872.6890
Classification Product Code
EGD  
Date Received10/31/1991
Decision Date 09/02/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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