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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 K950380
Device Name FLEXTITIP STYLETTE
Applicant
POLAMEDCO, INC.
8295 A. LACIENEGA BLVD.
INGLEWOOD,  CA  90301 -1521
Applicant Contact JERRY HARRER
Correspondent
POLAMEDCO, INC.
8295 A. LACIENEGA BLVD.
INGLEWOOD,  CA  90301 -1521
Correspondent Contact JERRY HARRER
Regulation Number868.5790
Classification Product Code
BSR  
Date Received01/31/1995
Decision Date 02/10/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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