The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Gasline Filter, #ec-glf Series.
| Device ID | K832935 |
| 510k Number | K832935 |
| Device Name: | GASLINE FILTER, #EC-GLF SERIES |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | GISH BIOMEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-30 |
| Decision Date | 1983-11-22 |