The following data is part of a premarket notification filed by Nipro Medical Corp. with the FDA for Nipro Safetouch Locktail Safety Fistula Needle.
| Device ID | K093985 |
| 510k Number | K093985 |
| Device Name: | NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE |
| Classification | Needle, Fistula |
| Applicant | NIPRO MEDICAL CORP. 3150 NW 107TH AVE. Miami, FL 33172 |
| Contact | Jessica Oswald |
| Correspondent | Jessica Oswald NIPRO MEDICAL CORP. 3150 NW 107TH AVE. Miami, FL 33172 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-24 |
| Decision Date | 2010-01-22 |
| Summary: | summary |