The following data is part of a premarket notification filed by Origio A/s with the FDA for Sage 1-step Gm-csf With Hsa, Sage 1-step Gm-csf With Sps.
Device ID | K172197 |
510k Number | K172197 |
Device Name: | SAGE 1-Step GM-CSF With HSA, SAGE 1-Step GM-CSF With SPS |
Classification | Media, Reproductive |
Applicant | ORIGIO A/s Knardrupvej 2 Malov, DK 2760 |
Contact | Tove Kjaer |
Correspondent | Tove Kjaer ORIGIO A/s Knardrupvej 2 Malov, DK 2760 |
Product Code | MQL |
CFR Regulation Number | 884.6180 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-21 |
Decision Date | 2017-10-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00888937833072 | K172197 | 000 |
00888937833058 | K172197 | 000 |