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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 K885139
Device Name MODIFIED ADULT CRICOTHYROIDOTOMY KIT
Applicant
Pertrach
Box 1158
109 Kelly Dr.
Bridgeport,  WV  26330
Applicant Contact TOYE, MD
Correspondent
Pertrach
Box 1158
109 Kelly Dr.
Bridgeport,  WV  26330
Correspondent Contact TOYE, MD
Regulation Number868.5800
Classification Product Code
BTO  
Date Received12/15/1988
Decision Date 05/25/1989
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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