The following data is part of a premarket notification filed by Genzyme Surgical Product (genzyme Biosurgery) with the FDA for Millennium Valve Introducer/rotator Handle.
| Device ID | K980016 |
| 510k Number | K980016 |
| Device Name: | MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE |
| Classification | Rotator, Prosthetic Heart Valve |
| Applicant | GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | MOP |
| CFR Regulation Number | 870.3935 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-02 |
| Decision Date | 1998-08-07 |
| Summary: | summary |