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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 K862909
Device Name RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEM
Applicant
Intl. Medical Devices , Ltd.
19355 Business Center Dr.
Suite 8
Northridge,  CA  91324
Applicant Contact MARCIA WEISS
Correspondent
Intl. Medical Devices , Ltd.
19355 Business Center Dr.
Suite 8
Northridge,  CA  91324
Correspondent Contact MARCIA WEISS
Regulation Number868.5800
Classification Product Code
BTO  
Date Received07/31/1986
Decision Date 09/09/1986
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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