The following data is part of a premarket notification filed by Fujifilm Medical Systems U.s.a., Inc. with the FDA for Fujifilm Double Balloon Endoscopes Models En-530t And En-580t.
| Device ID | K143556 |
| 510k Number | K143556 |
| Device Name: | Fujifilm Double Balloon Endoscopes Models EN-530T And EN-580T |
| Classification | Enteroscope And Accessories |
| Applicant | FUJIFILM MEDICAL SYSTEMS U.S.A., INC. 10 HIGH POINT DR Wayne, NJ 07470 |
| Contact | Mary Moore |
| Correspondent | Mary Moore FUJIFILM MEDICAL SYSTEMS U.S.A., INC. 10 HIGH POINT DR Wayne, NJ 07470 |
| Product Code | FDA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-15 |
| Decision Date | 2015-08-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410332100 | K143556 | 000 |
| 04547410332094 | K143556 | 000 |
| 04547410331646 | K143556 | 000 |