The following data is part of a premarket notification filed by Precision Optics Corp. with the FDA for Poc Ent Endoscope - Sinuscope.
| Device ID | K983123 |
| 510k Number | K983123 |
| Device Name: | POC ENT ENDOSCOPE - SINUSCOPE |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | PRECISION OPTICS CORP. 22 EAST BROADWAY Gardner, MA 01440 -3338 |
| Contact | James Reilly |
| Correspondent | James Reilly PRECISION OPTICS CORP. 22 EAST BROADWAY Gardner, MA 01440 -3338 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-01 |
| Decision Date | 1998-09-25 |
| Summary: | summary |