K890925 is an FDA 510(k) clearance for the MANAN BONE MARROW BIOPSY NEEDLE. This device is classified as a Needle, Biopsy, Cardiovascular (Class I - General Controls, product code DWO).
Submitted by Manan Medical Products, Inc. (Northbrook, US). The FDA issued a Cleared decision on April 11, 1989, 46 days after receiving the submission on February 24, 1989.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K890925 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 1989 |
| Decision Date | April 11, 1989 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | DWO — Needle, Biopsy, Cardiovascular |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |