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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 K962361
Device Name TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND
Applicant
Laerdal Medical Corp.
167 Myers Corners Rd.
P.O. Box 1840
Wappingers Falls,  NY  12590
Applicant Contact KENNETH B HERLAND
Correspondent
Laerdal Medical Corp.
167 Myers Corners Rd.
P.O. Box 1840
Wappingers Falls,  NY  12590
Correspondent Contact KENNETH B HERLAND
Regulation Number868.5790
Classification Product Code
BSR  
Date Received06/19/1996
Decision Date 09/05/1996
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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