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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 K881496
Device Name LINDER NASOTRACHEAL AIRWAY
Applicant
Polamedco, Inc.
1625 17th St.
Santa Monica,  CA  90404
Applicant Contact LINDER, MD
Correspondent
Polamedco, Inc.
1625 17th St.
Santa Monica,  CA  90404
Correspondent Contact LINDER, MD
Regulation Number868.5730
Classification Product Code
BTR  
Date Received04/08/1988
Decision Date 05/31/1988
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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