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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 K901920
Device Name PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE
Applicant
Primecare, Inc.
23991 Ironhead Ln.
Laguna Niguel,  CA  92677
Applicant Contact JOSEPH H BALES
Correspondent
Primecare, Inc.
23991 Ironhead Ln.
Laguna Niguel,  CA  92677
Correspondent Contact JOSEPH H BALES
Regulation Number868.5800
Classification Product Code
BTO  
Date Received04/30/1990
Decision Date 08/17/1990
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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