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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 K954771
Device Name TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)
Applicant
LAERDAL MEDICAL CORP.
167 MYERS CORNERS RD.
P.O. BOX 1840
WAPPINGERS FALLS,  NY  12590 -8840
Applicant Contact KEN HERLAND
Correspondent
LAERDAL MEDICAL CORP.
167 MYERS CORNERS RD.
P.O. BOX 1840
WAPPINGERS FALLS,  NY  12590 -8840
Correspondent Contact KEN HERLAND
Regulation Number868.5790
Classification Product Code
BSR  
Date Received10/17/1995
Decision Date 05/09/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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