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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 K935616
Device Name SALIVA EJECTOR DISPOSABLE
Applicant
ASA INSTRUMENTS S.R.L.
VIA VALENZANA, 4
55050 BOZZANO
MASSAROSA (LUCCA) ITALY,  IT
Applicant Contact MARIE KINKELA
Correspondent
ASA INSTRUMENTS S.R.L.
VIA VALENZANA, 4
55050 BOZZANO
MASSAROSA (LUCCA) ITALY,  IT
Correspondent Contact MARIE KINKELA
Regulation Number872.6640
Classification Product Code
DYN  
Date Received11/22/1993
Decision Date 03/21/1994
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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