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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K923591
Device Name PALA-NATE
Applicant
Gesco Intl., Inc.
P.O. Box 690188
San Antonio,  TX  78269
Applicant Contact JAME K KLEIN
Correspondent
Gesco Intl., Inc.
P.O. Box 690188
San Antonio,  TX  78269
Correspondent Contact JAME K KLEIN
Regulation Number868.5730
Classification Product Code
BTR  
Date Received07/20/1992
Decision Date 03/16/1993
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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