The following data is part of a premarket notification filed by Top Surgical Manufacturers Co. with the FDA for Top Single Use U.t.w. A-v Fistula Needle Y Type.
| Device ID | K844343 |
| 510k Number | K844343 |
| Device Name: | TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE |
| Classification | Needle, Fistula |
| Applicant | TOP SURGICAL MANUFACTURERS CO. 7660 WEST FREMONT AVE. Littleton, CO 80123 |
| Contact | Tod Imamura |
| Correspondent | Tod Imamura TOP SURGICAL MANUFACTURERS CO. 7660 WEST FREMONT AVE. Littleton, CO 80123 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-09 |
| Decision Date | 1985-01-08 |