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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Evacuator, Oral Cavity
510(k) Number K941164
Device Name TAP EXPRESS EJECTOR
Applicant
Tap Express, Inc.
12300 SW 131 Ave.
Miami,  FL  33186
Applicant Contact CLAUDIO NEPI
Correspondent
Tap Express, Inc.
12300 SW 131 Ave.
Miami,  FL  33186
Correspondent Contact CLAUDIO NEPI
Regulation Number872.6640
Classification Product Code
EHZ  
Date Received03/11/1994
Decision Date 05/18/1994
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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