The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Hemed Needle Support Catalog No. Hap-xxxx.
| Device ID | K853731 |
| 510k Number | K853731 |
| Device Name: | HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
| Contact | Jeanne Pierson |
| Correspondent | Jeanne Pierson GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-06 |
| Decision Date | 1985-10-18 |