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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 K871315
Device Name ORAL ASPIRATOR
Applicant
Endovations
895 Poplar Church Rd.
Camp Hill,  PA  17011
Applicant Contact LIFTON, MD
Correspondent
Endovations
895 Poplar Church Rd.
Camp Hill,  PA  17011
Correspondent Contact LIFTON, MD
Regulation Number872.6640
Classification Product Code
DYN  
Date Received04/01/1987
Decision Date 04/15/1987
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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