The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Microendoscope.
| Device ID | K063078 |
| 510k Number | K063078 |
| Device Name: | MICROENDOSCOPE |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park, CA 94025 |
| Contact | Debbie Cogan |
| Correspondent | Debbie Cogan ACCLARENT, INC. 1525-B O'BRIEN DR. Menlo Park, CA 94025 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-10 |
| Decision Date | 2006-10-24 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MICROENDOSCOPE 74521200 not registered Dead/Abandoned |
OPTMED TECHNOLOGIES, INC. 1994-05-04 |