The following data is part of a premarket notification filed by Fujifilm Medical Systems U.s.a., Inc. with the FDA for Fujifilm Hood Models Dh-28gr, Dh-29cr And Dh-30cr.
| Device ID | K162749 |
| 510k Number | K162749 |
| Device Name: | FUJIFILM Hood Models DH-28GR, DH-29CR And DH-30CR |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | FUJIFILM Medical Systems U.S.A., Inc. 10 High Point Drive Wayne, NJ 07470 |
| Contact | Shraddha S. More |
| Correspondent | Shraddha S. More FUJIFILM Medical Systems U.S.A., Inc. 10 High Point Drive Wayne, NJ 07470 |
| Product Code | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-30 |
| Decision Date | 2017-06-15 |
| Summary: | summary |