The following data is part of a premarket notification filed by Mill-rose Laboratory with the FDA for Pleura Biopsy Device.
| Device ID | K901995 |
| 510k Number | K901995 |
| Device Name: | PLEURA BIOPSY DEVICE |
| Classification | Needle, Aspiration And Injection, Reusable |
| 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 | GDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-02 |
| Decision Date | 1990-07-10 |