The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Gish Tubing And Connectors With Ha Coating.
| Device ID | K081881 |
| 510k Number | K081881 |
| Device Name: | GISH TUBING AND CONNECTORS WITH HA COATING |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | GISH BIOMEDICAL, INC. 22942 ARROYO VISTA Rancho Santa Margarita, CA 92688 |
| Contact | Edward F Waddell |
| Correspondent | Edward F Waddell GISH BIOMEDICAL, INC. 22942 ARROYO VISTA Rancho Santa Margarita, CA 92688 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-02 |
| Decision Date | 2009-01-23 |
| Summary: | summary |