The following data is part of a premarket notification filed by Mill-rose Laboratory with the FDA for Thoracentisis Kit.
| Device ID | K894326 |
| 510k Number | K894326 |
| Device Name: | THORACENTISIS KIT |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | MILL-ROSE LABORATORY 7310 CORPORATE BLVD. Mentor, OH 44060 -4885 |
| Contact | Mark Kozak |
| Correspondent | Mark Kozak MILL-ROSE LABORATORY 7310 CORPORATE BLVD. Mentor, OH 44060 -4885 |
| Product Code | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-14 |
| Decision Date | 1989-07-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10653405058267 | K894326 | 000 |
| 10653405058250 | K894326 | 000 |
| 10653405052852 | K894326 | 000 |
| 10653405052838 | K894326 | 000 |