The following data is part of a premarket notification filed by Reichert-jung, Inc. with the FDA for Airway Fiberscopes, Models Ls-9, 0l-1, 0l-2 & Pl-2.
| Device ID | K864821 |
| 510k Number | K864821 |
| Device Name: | AIRWAY FIBERSCOPES, MODELS LS-9, 0L-1, 0L-2 & PL-2 |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | REICHERT-JUNG, INC. 122 CHARLTON ST. Southbridge, MA 01550 |
| Contact | Richard F Taylor |
| Correspondent | Richard F Taylor REICHERT-JUNG, INC. 122 CHARLTON ST. Southbridge, MA 01550 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-09 |
| Decision Date | 1987-02-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858119004026 | K864821 | 000 |
| 00858119004019 | K864821 | 000 |