The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Orthofuser Wound Drainage/autotransfusion System.
| Device ID | K912019 |
| 510k Number | K912019 |
| Device Name: | ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
| Contact | Debi Kridner |
| Correspondent | Debi Kridner GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-07 |
| Decision Date | 1991-10-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10803622132190 | K912019 | 000 |
| 10803622130776 | K912019 | 000 |
| 10803622130783 | K912019 | 000 |
| 10803622130790 | K912019 | 000 |
| 10803622130806 | K912019 | 000 |
| 10803622132138 | K912019 | 000 |
| 10803622132152 | K912019 | 000 |
| 10803622132169 | K912019 | 000 |
| 10803622132176 | K912019 | 000 |
| 10803622132183 | K912019 | 000 |
| 10803622130769 | K912019 | 000 |