The following data is part of a premarket notification filed by Fiber Imaging Technologies, Inc. with the FDA for Naso-laryngo-pharyngoscope.
| Device ID | K991560 |
| 510k Number | K991560 |
| Device Name: | NASO-LARYNGO-PHARYNGOSCOPE |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | FIBER IMAGING TECHNOLOGIES, INC. 45 PONTIAC RD. Newton, MA 02468 |
| Contact | Joseph Ress |
| Correspondent | Joseph Ress FIBER IMAGING TECHNOLOGIES, INC. 45 PONTIAC RD. Newton, MA 02468 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-04 |
| Decision Date | 1999-07-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994455383 | K991560 | 000 |
| 00885074017747 | K991560 | 000 |