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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 K922842
Device Name STYLET AND TRACHEAL LIGHTWAND (STL)
Applicant
Laerdal California, Inc.
1901 Obispo Ave.
Long Beach,  CA  90804
Applicant Contact SAM E STEPHENS
Correspondent
Laerdal California, Inc.
1901 Obispo Ave.
Long Beach,  CA  90804
Correspondent Contact SAM E STEPHENS
Regulation Number868.5790
Classification Product Code
BSR  
Date Received06/12/1992
Decision Date 12/18/1992
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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