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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheostomy (W/Wo Connector)
510(k) Number K801379
Device Name CUFFED TRACHEA TUBE FOR USE W/PERTRACH
Applicant
FREDERIC J. TOYE, M.D.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
FREDERIC J. TOYE, M.D.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5800
Classification Product Code
BTO  
Date Received06/11/1980
Decision Date 09/09/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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