The following data is part of a premarket notification filed by Top Surgical Manufacturers Co. with the FDA for Tops Dispos. Infusion Set/hemodialysis.
| Device ID | K841119 |
| 510k Number | K841119 |
| Device Name: | TOPS DISPOS. INFUSION SET/HEMODIALYSIS |
| Classification | Accessories, A-v Shunt |
| Applicant | TOP SURGICAL MANUFACTURERS CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KNZ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-15 |
| Decision Date | 1984-04-20 |