The following data is part of a premarket notification filed by Irvine Scientific Sales Co., Inc. with the FDA for Arctic Sperm Cryopreservation Medium.
| Device ID | K171224 |
| 510k Number | K171224 |
| Device Name: | Arctic Sperm Cryopreservation Medium |
| Classification | Media, Reproductive |
| Applicant | Irvine Scientific Sales Co., Inc. 2511 Daimler Street Santa Ana, CA 92705 |
| Contact | Jayme Yamaguchi-owens |
| Correspondent | Jayme Yamaguchi-owens Irvine Scientific Sales Co., Inc. 2511 Daimler Street Santa Ana, CA 92705 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-26 |
| Decision Date | 2017-08-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857515006252 | K171224 | 000 |
| 00857515006436 | K171224 | 000 |