The following data is part of a premarket notification filed by Top Corp. with the FDA for Modification Top Ultra Thinwall A-v Fistula Needle.
| Device ID | K860449 |
| 510k Number | K860449 |
| Device Name: | MODIFICATION TOP ULTRA THINWALL A-V FISTULA NEEDLE |
| Classification | Needle, Fistula |
| Applicant | TOP CORP. 7660 WEST FREEMONT AVE. Littleton, CO 80123 |
| Contact | Tadayoshi Imamura |
| Correspondent | Tadayoshi Imamura TOP CORP. 7660 WEST FREEMONT 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 | 1986-02-04 |
| Decision Date | 1986-02-26 |