The following data is part of a premarket notification filed by Smith & Nephew, Mpl Division with the FDA for Hypo Brand Dispos. Dental Needles-plast.
| Device ID | K833304 |
| 510k Number | K833304 |
| Device Name: | HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST |
| Classification | Needle, Dental |
| Applicant | SMITH & NEPHEW, MPL DIVISION 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DZM |
| CFR Regulation Number | 872.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-23 |
| Decision Date | 1984-03-30 |