The following data is part of a premarket notification filed by Uresil Corp. with the FDA for Uresil Introducing Needle.
| Device ID | K953923 |
| 510k Number | K953923 |
| Device Name: | URESIL INTRODUCING NEEDLE |
| Classification | Instrument, Biopsy |
| Applicant | URESIL CORP. 5418 W. TOUHY AVE. Skokie, IL 60077 |
| Contact | Matthew Curtis |
| Correspondent | Matthew Curtis URESIL CORP. 5418 W. TOUHY AVE. Skokie, IL 60077 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-18 |
| Decision Date | 1995-09-08 |