The following data is part of a premarket notification filed by Advanced Surgical Products, Inc. with the FDA for Ryan-style Directed Infusion Manipulator.
| Device ID | K890398 |
| 510k Number | K890398 |
| Device Name: | RYAN-STYLE DIRECTED INFUSION MANIPULATOR |
| Classification | Illuminator, Fiberoptic, Surgical Field |
| Applicant | ADVANCED SURGICAL PRODUCTS, INC. 750 GODDARD AVE. Chesterfield, MO 63005 |
| Contact | Todd J Hessel |
| Correspondent | Todd J Hessel ADVANCED SURGICAL PRODUCTS, INC. 750 GODDARD AVE. Chesterfield, MO 63005 |
| Product Code | HBI |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-24 |
| Decision Date | 1989-02-17 |