The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed Encore(tm) Advantage Kit/essentials Kit.
| Device ID | K925608 |
| 510k Number | K925608 |
| Device Name: | SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT |
| Classification | Endothelial Cell Harvesting Kit |
| Applicant | SCIMED LIFE SYSTEMS, INC. 6655 WEDGWOOD RD. Maple Grove, MN 55369 |
| Contact | Mercedes P Bayani |
| Correspondent | Mercedes P Bayani SCIMED LIFE SYSTEMS, INC. 6655 WEDGWOOD RD. Maple Grove, MN 55369 |
| Product Code | MFY |
| CFR Regulation Number | 870.4075 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-05 |
| Decision Date | 1993-06-16 |