The following data is part of a premarket notification filed by Fujifilm Medical Systems U.s.a., Inc. with the FDA for Balloon Controller Pb-30.
| Device ID | K153483 |
| 510k Number | K153483 |
| Device Name: | Balloon Controller PB-30 |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | FUJIFILM MEDICAL SYSTEMS U.S.A., INC. 10 HIGH POINT DR Wayne, NJ 07470 |
| Contact | Aaron Ge |
| Correspondent | Aaron Ge FUJIFILM MEDICAL SYSTEMS U.S.A., INC. 10 HIGH POINT DR Wayne, NJ 07470 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-03 |
| Decision Date | 2015-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410332063 | K153483 | 000 |