The following data is part of a premarket notification filed by Mill-rose Laboratory with the FDA for Mill-rose Laboratories Transbronchial Needle Aspiration (tbna) Cytology Procedural Kit.
| Device ID | K983124 |
| 510k Number | K983124 |
| Device Name: | MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT |
| Classification | Bronchoscope (flexible Or Rigid) |
| 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 | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-08 |
| Decision Date | 1998-10-30 |
| Summary: | summary |