The following data is part of a premarket notification filed by Downs Surgical Ltd. with the FDA for Islam Sternal Puncture Needle, Cat # Af-594-00-v.
| Device ID | K903748 |
| 510k Number | K903748 |
| Device Name: | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V |
| Classification | Needle, Aspiration And Injection, Reusable |
| Applicant | DOWNS SURGICAL LTD. PARKWAY CLOSE,PARKWAY INDUSTRIAL ESTATE Sheffield S9 4wj, GB |
| Contact | A. J Newson |
| Correspondent | A. J Newson DOWNS SURGICAL LTD. PARKWAY CLOSE,PARKWAY INDUSTRIAL ESTATE Sheffield S9 4wj, GB |
| Product Code | GDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-16 |
| Decision Date | 1990-10-31 |