The following data is part of a premarket notification filed by Nipro Medical Corp. with the FDA for Nipro Safetouch Safety Fistula Needle.
| Device ID | K002813 |
| 510k Number | K002813 |
| Device Name: | NIPRO SAFETOUCH SAFETY FISTULA NEEDLE |
| Classification | Needle, Fistula |
| Applicant | NIPRO MEDICAL CORP. 510 STONEMONT DR. Weston, FL 33326 |
| Contact | Richard D Bliss |
| Correspondent | Richard D Bliss NIPRO MEDICAL CORP. 510 STONEMONT DR. Weston, FL 33326 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-08 |
| Decision Date | 2000-11-21 |