The following data is part of a premarket notification filed by Fujinon, Inc. with the FDA for Fujinon Double Balloon Enteroscopy System.
| Device ID | K040048 |
| 510k Number | K040048 |
| Device Name: | FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM |
| Classification | Enteroscope And Accessories |
| Applicant | FUJINON, INC. P.O. BOX 2156 Huntington, CT 06484 |
| Contact | Joseph M Azary |
| Correspondent | Joseph M Azary FUJINON, INC. P.O. BOX 2156 Huntington, CT 06484 |
| Product Code | FDA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-12 |
| Decision Date | 2004-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410330960 | K040048 | 000 |
| 04547410330953 | K040048 | 000 |