The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Medos Hilite Infant Oxygenator, Model 1000, 800 Lt.
| Device ID | K090449 |
| 510k Number | K090449 |
| Device Name: | MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | GISH BIOMEDICAL, INC. 22942 ARROYO VISTA Rancho Santa Margarita, CA 92688 |
| Contact | Janet Peets |
| Correspondent | Janet Peets GISH BIOMEDICAL, INC. 22942 ARROYO VISTA Rancho Santa Margarita, CA 92688 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-20 |
| Decision Date | 2009-09-18 |
| Summary: | summary |