The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Nipro Safetouch Tulip Safety Fistula Needle.
| Device ID | K071145 |
| 510k Number | K071145 |
| Device Name: | NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE |
| Classification | Catheter, Hemodialysis, Non-implanted |
| Applicant | NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. Miami, FL 33172 |
| Contact | Jessica Oswald |
| Correspondent | Jessica Oswald NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. Miami, FL 33172 |
| Product Code | MPB |
| Subsequent Product Code | KOC |
| Subsequent Product Code | LLB |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-24 |
| Decision Date | 2007-09-07 |
| Summary: | summary |