The following data is part of a premarket notification filed by Galemed Corp. with the FDA for Af Viral/bacterial Filter, Bf Viral/bacterial Filter.
| Device ID | K132679 |
| 510k Number | K132679 |
| Device Name: | AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | GALEMED CORP. 29201 VIA NORTE Temecula, CA 92591 |
| Contact | Tom Shanks |
| Correspondent | Tom Shanks GALEMED CORP. 29201 VIA NORTE Temecula, CA 92591 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-28 |
| Decision Date | 2014-04-18 |