K983621 is an FDA 510(k) clearance for the NEEDLE GUIDE. This device is classified as a System, X-ray, Mammographic (Class II - Special Controls, product code IZH).
Submitted by Remington Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on November 3, 1998, 19 days after receiving the submission on October 15, 1998.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1710.
| 510(k) Number | K983621 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 1998 |
| Decision Date | November 03, 1998 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IZH - System, X-ray, Mammographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1710 |