The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Meconium Aspirator.
| Device ID | K893649 |
| 510k Number | K893649 |
| Device Name: | MECONIUM ASPIRATOR |
| Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Applicant | GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
| Contact | Lori Glastetter |
| Correspondent | Lori Glastetter GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
| Product Code | GCX |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-15 |
| Decision Date | 1989-08-21 |