The following data is part of a premarket notification filed by Origio, Inc with the FDA for Origio Gas Line Filter.
Device ID | K132870 |
510k Number | K132870 |
Device Name: | Origio Gas Line Filter |
Classification | Accessory, Assisted Reproduction |
Applicant | ORIGIO, INC 2400 HUNTERS WAY Charlottesville, VA 22911 |
Contact | John Clay |
Correspondent | John Clay ORIGIO, INC 2400 HUNTERS WAY Charlottesville, VA 22911 |
Product Code | MQG |
CFR Regulation Number | 884.6120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-09-13 |
Decision Date | 2014-05-07 |
Summary: | summary |