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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protector, Dental
510(k) Number K935713
Device Name WILEY/ESPOSITO DENTAL GUARD
Applicant
Fvtnks
10415 Briggs Ct.
Indianapolis,  IN  46256 -9719
Applicant Contact PAUL E DRYDEN
Correspondent
Fvtnks
10415 Briggs Ct.
Indianapolis,  IN  46256 -9719
Correspondent Contact PAUL E DRYDEN
Regulation Number868.5820
Classification Product Code
BRW  
Date Received11/30/1993
Decision Date 01/05/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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