The following data is part of a premarket notification filed by Mill-rose Laboratory with the FDA for Mill-rose Percutaneous Procedural Kit.
| Device ID | K935858 |
| 510k Number | K935858 |
| Device Name: | MILL-ROSE PERCUTANEOUS PROCEDURAL KIT |
| Classification | General Surgery Tray |
| Applicant | MILL-ROSE LABORATORY 7310 CORPORATE BLVD. Mentor, OH 44060 -4885 |
| Contact | Alan C Poje |
| Correspondent | Alan C Poje MILL-ROSE LABORATORY 7310 CORPORATE BLVD. Mentor, OH 44060 -4885 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-08 |
| Decision Date | 1994-02-22 |