K903749 is an FDA 510(k) clearance for the ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U. This device is classified as a Needle, Aspiration And Injection, Reusable (Class I - General Controls, product code GDM).
Submitted by Downs Surgical , Ltd. (Sheffield S9 4wj, GB). The FDA issued a Cleared decision on October 31, 1990, 76 days after receiving the submission on August 16, 1990.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K903749 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 1990 |
| Decision Date | October 31, 1990 |
| Days to Decision | 76 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 |