The following data is part of a premarket notification filed by Laerdal California, Inc. with the FDA for Stylet And Tracheal Lightwand (stl).
Device ID | K922842 |
510k Number | K922842 |
Device Name: | STYLET AND TRACHEAL LIGHTWAND (STL) |
Classification | Stylet, Tracheal Tube |
Applicant | LAERDAL CALIFORNIA, INC. 1901 OBISPO AVE. Long Beach, CA 90804 |
Contact | Sam E Stephens |
Correspondent | Sam E Stephens LAERDAL CALIFORNIA, INC. 1901 OBISPO AVE. Long Beach, CA 90804 |
Product Code | BSR |
CFR Regulation Number | 868.5790 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-12 |
Decision Date | 1992-12-18 |