The following data is part of a premarket notification filed by Effner, Inc. with the FDA for Fiber Optic Laryngoscope.
| Device ID | K883830 |
| 510k Number | K883830 |
| Device Name: | FIBER OPTIC LARYNGOSCOPE |
| Classification | Laryngoscope, Rigid |
| Applicant | EFFNER, INC. POST OFFICE BOX 191 Port Washington, NY 11050 |
| Contact | Inge Hamer |
| Correspondent | Inge Hamer EFFNER, INC. POST OFFICE BOX 191 Port Washington, NY 11050 |
| Product Code | CCW |
| CFR Regulation Number | 868.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-09 |
| Decision Date | 1988-10-25 |