K923872 is an FDA 510(k) clearance for the BONE MARROW BIOPSY SYSTEM. This device is classified as a Needle, Aspiration And Injection, Reusable (Class I — General Controls, product code GDM).
Submitted by The Straumann Co. (Cambridge, US). The FDA issued a Cleared decision on December 15, 1992, 134 days after receiving the submission on August 3, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K923872 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 03, 1992 |
| Decision Date | December 15, 1992 |
| Days to Decision | 134 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GDM — Needle, Aspiration And Injection, Reusable |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |