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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saliva, Artificial
510(k) Number K851026
Device Name MOI-STIR ORAL SWABSTICK(S)
Applicant
Kingswood Laboratories, Inc.
336 Heather Dr.
Carmel,  IN  46032
Applicant Contact THOMAS W MCINTYRE
Correspondent
Kingswood Laboratories, Inc.
336 Heather Dr.
Carmel,  IN  46032
Correspondent Contact THOMAS W MCINTYRE
Classification Product Code
LFD  
Date Received03/12/1985
Decision Date 05/21/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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