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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 K914743
Device Name EMERGENCY PERCUTANEOUS CRICOTHYROIDOTOMY KIT,MODIF
Applicant
PERTRACH
BOX 1158
109 KELLY DR.
BRIDGEPORT,  WV  26330
Applicant Contact FREDERIC J TOYE
Correspondent
PERTRACH
BOX 1158
109 KELLY DR.
BRIDGEPORT,  WV  26330
Correspondent Contact FREDERIC J TOYE
Regulation Number868.5800
Classification Product Code
BTO  
Date Received10/11/1991
Decision Date 07/10/1992
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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