The following data is part of a premarket notification filed by Fiberoptic Medical Products, Inc. with the FDA for Fiberoptic Laryngoscope Handle.
| Device ID | K944686 |
| 510k Number | K944686 |
| Device Name: | FIBEROPTIC LARYNGOSCOPE HANDLE |
| Classification | Laryngoscope, Rigid |
| Applicant | FIBEROPTIC MEDICAL PRODUCTS, INC. 5100 TILGHMAN ST., SUITE 300 Allentown, PA 18104 |
| Contact | Richard W Holt |
| Correspondent | Richard W Holt FIBEROPTIC MEDICAL PRODUCTS, INC. 5100 TILGHMAN ST., SUITE 300 Allentown, PA 18104 |
| Product Code | CCW |
| CFR Regulation Number | 868.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-23 |
| Decision Date | 1994-11-04 |