K901995 is an FDA 510(k) clearance for the PLEURA BIOPSY DEVICE. This device is classified as a Needle, Aspiration And Injection, Reusable (Class I - General Controls, product code GDM).
Submitted by Mill-Rose Laboratory (Mentor, US). The FDA issued a Cleared decision on July 10, 1990, 69 days after receiving the submission on May 2, 1990.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K901995 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 1990 |
| Decision Date | July 10, 1990 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GDM — Needle, Aspiration And Injection, Reusable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |