The following data is part of a premarket notification filed by Laerdal Medical Corp. with the FDA for Trachlight Stylet And Tracheal Lightwand.
| Device ID | K962361 |
| 510k Number | K962361 |
| Device Name: | TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND |
| Classification | Stylet, Tracheal Tube |
| Applicant | LAERDAL MEDICAL CORP. 167 MYERS CORNERS RD. P.O. BOX 1840 Wappingers Falls, NY 12590 -8840 |
| Contact | Kenneth B Herland |
| Correspondent | Kenneth B Herland LAERDAL MEDICAL CORP. 167 MYERS CORNERS RD. P.O. BOX 1840 Wappingers Falls, NY 12590 -8840 |
| Product Code | BSR |
| CFR Regulation Number | 868.5790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-19 |
| Decision Date | 1996-09-05 |