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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 K830509
Device Name EMERGENCY TRACHEOSTOMY & CRICOTHYROIDO-
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 Received02/17/1983
Decision Date 03/29/1983
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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