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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K981744
Device Name COMBINATION TOA WITH NASAL MASK HOLDER AND UNIVERSAL NASAL MASK HOLDER
Applicant
W. Keith Thornton, D.D.S.
6131 Luther Ln., Suite 208
Dallas,  TX  75225
Applicant Contact W.KEITH THORNTON
Correspondent
W. Keith Thornton, D.D.S.
6131 Luther Ln., Suite 208
Dallas,  TX  75225
Correspondent Contact W.KEITH THORNTON
Regulation Number868.5905
Classification Product Code
BZD  
Date Received05/18/1998
Decision Date 10/14/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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