The following data is part of a premarket notification filed by Fujinon, Inc. with the FDA for Fujinon Sterile Overtubes.
| Device ID | K091773 |
| 510k Number | K091773 |
| Device Name: | FUJINON STERILE OVERTUBES |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | FUJINON, INC. 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Contact | Joseph M Azary |
| Correspondent | Joseph M Azary FUJINON, INC. 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-16 |
| Decision Date | 2009-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410331509 | K091773 | 000 |
| 04547410331493 | K091773 | 000 |
| 04547410331516 | K091773 | 000 |