K913815 is an FDA 510(k) clearance for the AUTOMATED BIOPSY DEVICE, MODIFICATION. This device is classified as a Needle, Biopsy, Cardiovascular (Class I - General Controls, product code DWO).
Submitted by Hart Enterprises, Inc. (Wyoming, US). The FDA issued a Cleared decision on October 30, 1991, 65 days after receiving the submission on August 26, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K913815 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 1991 |
| Decision Date | October 30, 1991 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | DWO — Needle, Biopsy, Cardiovascular |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |