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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 K871199
Device Name MODIFIED PERTRACH DISP. PEDIATRIC PERCUT. TRACHEO.
Applicant
Frederic J. Toye, M.D.
Suite 105 Doctors Office Bldg.
#4 Hospital Plaza
Clarksburg,  WV  26301
Correspondent
Frederic J. Toye, M.D.
Suite 105 Doctors Office Bldg.
#4 Hospital Plaza
Clarksburg,  WV  26301
Regulation Number868.5800
Classification Product Code
BTO  
Date Received03/25/1987
Decision Date 06/08/1987
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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