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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthpiece, Saliva Ejector
510(k) Number K863163
Device Name ULS 8-86
Applicant
American Instrument Manufacturer'S, Inc.
P.O. Box 690
Eureka,  MO  63025
Applicant Contact TERRY SANDERSON
Correspondent
American Instrument Manufacturer'S, Inc.
P.O. Box 690
Eureka,  MO  63025
Correspondent Contact TERRY SANDERSON
Regulation Number872.6640
Classification Product Code
DYN  
Date Received08/18/1986
Decision Date 09/22/1986
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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