The following data is part of a premarket notification filed by Pollux Endoscopy, Inc. with the FDA for Sinuscope And Baccessories.
| Device ID | K002214 |
| 510k Number | K002214 |
| Device Name: | SINUSCOPE AND BACCESSORIES |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | POLLUX ENDOSCOPY, INC. 2404 AIRPORT RD., SUITE 2 Plant City, FL 33567 |
| Contact | Precious J Resch |
| Correspondent | Precious J Resch POLLUX ENDOSCOPY, INC. 2404 AIRPORT RD., SUITE 2 Plant City, FL 33567 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-24 |
| Decision Date | 2000-11-21 |