The following data is part of a premarket notification filed by Avail Medical Products, Inc. with the FDA for Prefilled Catheter Inflation Syringe.
| Device ID | K112209 |
| 510k Number | K112209 |
| Device Name: | PREFILLED CATHETER INFLATION SYRINGE |
| Classification | Accessories, Catheter, G-u |
| Applicant | AVAIL MEDICAL PRODUCTS, INC. 5950 NANCY RIDGE ROAD SUITE 500 San Diego, CA 92121 |
| Contact | Steven A Howell |
| Correspondent | Steven A Howell AVAIL MEDICAL PRODUCTS, INC. 5950 NANCY RIDGE ROAD SUITE 500 San Diego, CA 92121 |
| Product Code | KNY |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-01 |
| Decision Date | 2011-09-08 |
| Summary: | summary |