The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Modification To Gyrus Acmi Invisio Icn, Models Icn-0564 And Icn-0565.
| Device ID | K090814 |
| 510k Number | K090814 |
| Device Name: | MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Graham A.l. Baillie |
| Correspondent | Graham A.l. Baillie GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-25 |
| Decision Date | 2009-04-20 |
| Summary: | summary |