The following data is part of a premarket notification filed by Avail Medical Products, Inc. with the FDA for Pre-filled Catheter Inflation Syringe.
| Device ID | K090121 |
| 510k Number | K090121 |
| Device Name: | PRE-FILLED CATHETER INFLATION SYRINGE |
| Classification | Accessories, Catheter, G-u |
| Applicant | AVAIL MEDICAL PRODUCTS, INC. 1900 EAST CARNEGIE AVE. Santa Ana, CA 92705 |
| Contact | Patricia A Goeree |
| Correspondent | Patricia A Goeree AVAIL MEDICAL PRODUCTS, INC. 1900 EAST CARNEGIE AVE. Santa Ana, CA 92705 |
| Product Code | KNY |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-21 |
| Decision Date | 2009-04-15 |
| Summary: | summary |