The following data is part of a premarket notification filed by Truphatek, Ltd. with the FDA for Laryngoscope Blades.
| Device ID | K883414 |
| 510k Number | K883414 |
| Device Name: | LARYNGOSCOPE BLADES |
| Classification | Laryngoscope, Rigid |
| Applicant | TRUPHATEK, LTD. P.O. BOX 8051 Netanya, IL 42106 |
| Contact | David Grey |
| Correspondent | David Grey TRUPHATEK, LTD. P.O. BOX 8051 Netanya, IL 42106 |
| Product Code | CCW |
| CFR Regulation Number | 868.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-15 |
| Decision Date | 1988-08-19 |