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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 K900457
Device Name CUFFED LINDER NASOTRACHEAL AIRWAY
Applicant
Polamedco, Inc.
8295 S.La Cienega Blvd.
Inglewood,  CA  90301
Applicant Contact LINDER, MD
Correspondent
Polamedco, Inc.
8295 S.La Cienega Blvd.
Inglewood,  CA  90301
Correspondent Contact LINDER, MD
Regulation Number868.5730
Classification Product Code
BTR  
Date Received01/30/1990
Decision Date 04/16/1990
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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