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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 K861934
Device Name SALIVA EJECTOR
Applicant
Carlisle Laboratories, Inc.
404 Doughty Blvd.
Inwood,  NY  11696
Applicant Contact MICHAEL STEHN
Correspondent
Carlisle Laboratories, Inc.
404 Doughty Blvd.
Inwood,  NY  11696
Correspondent Contact MICHAEL STEHN
Regulation Number872.6640
Classification Product Code
DYN  
Date Received05/20/1986
Decision Date 06/09/1986
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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