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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stylet, Tracheal Tube
510(k) Number K950713
Device Name AIRGUIDE STYLETTE
Applicant
Polamedco, Inc.
8295 S.La Cienega Blvd.
Inglewood,  CA  90301 -1521
Applicant Contact JERRY W HARRER
Correspondent
Polamedco, Inc.
8295 S.La Cienega Blvd.
Inglewood,  CA  90301 -1521
Correspondent Contact JERRY W HARRER
Regulation Number868.5790
Classification Product Code
BSR  
Date Received02/15/1995
Decision Date 05/17/1995
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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