The following data is part of a premarket notification filed by Fresenius Medical Care with the FDA for Fresenius Punctur-guard Fistula Needle Sets.
| Device ID | K023162 |
| 510k Number | K023162 |
| Device Name: | FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS |
| Classification | Needle, Fistula |
| Applicant | FRESENIUS MEDICAL CARE 95 HAYDEN AVE. Lexington, MA 02420 |
| Contact | Nichole Riek |
| Correspondent | Nichole Riek FRESENIUS MEDICAL CARE 95 HAYDEN AVE. Lexington, MA 02420 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-23 |
| Decision Date | 2003-03-20 |
| Summary: | summary |