The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Flexible Endoscope 91-8200(90) And 91-82100(135).
| Device ID | K884631 |
| 510k Number | K884631 |
| Device Name: | FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135) |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Contact | Gordon Peters |
| Correspondent | Gordon Peters XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Product Code | LRC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-07 |
| Decision Date | 1989-03-22 |