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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
Applicant Contact KEN HERLAND
Correspondent
Laerdal Medical Corp.
167 Myers Corners Rd.
P.O. Box 1840
Wappingers Falls,  NY  12590
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
Predetermined Change
Control Plan Authorized		 No
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