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 |