The following data is part of a premarket notification filed by At Medical Uab with the FDA for Miri Tl.
Device ID | K151357 |
510k Number | K151357 |
Device Name: | MIRI TL |
Classification | Accessory, Assisted Reproduction |
Applicant | AT MEDICAL UAB DRAUGYSTES G.19 Kaunas, LT 51230 |
Contact | Thomas Pedersen |
Correspondent | Thomas Pedersen AT MEDICAL UAB DRAUGYSTES G.19 Kaunas, LT 51230 |
Product Code | MQG |
CFR Regulation Number | 884.6120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-05-20 |
Decision Date | 2016-04-22 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04779041940113 | K151357 | 000 |