The following data is part of a premarket notification filed by Reprolife Inc. with the FDA for Cryotec.
| Device ID | K162051 |
| 510k Number | K162051 |
| Device Name: | Cryotec |
| Classification | Labware, Assisted Reproduction |
| Applicant | REPROLIFE INC. 2-5-5-8F, SHINJUKU Shinjuku-ku, JP 160-0022 |
| Contact | Koichi Takeda |
| Correspondent | Diane Sudduth EMERGO GROUP 816 CONGRESS AVENUE, SUITE 1400 Austin, TX 78701 |
| Product Code | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-25 |
| Decision Date | 2016-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04589700010206 | K162051 | 000 |
| 04589700010091 | K162051 | 000 |
| 04589700010084 | K162051 | 000 |
| 04589700010077 | K162051 | 000 |
| 04589700010060 | K162051 | 000 |
| 04589700010053 | K162051 | 000 |
| 04589700010046 | K162051 | 000 |
| 04589700010039 | K162051 | 000 |
| 04589700010022 | K162051 | 000 |
| 04589700010107 | K162051 | 000 |
| 04589700010114 | K162051 | 000 |
| 04589700010190 | K162051 | 000 |
| 04589700010183 | K162051 | 000 |
| 04589700010176 | K162051 | 000 |
| 04589700010169 | K162051 | 000 |
| 04589700010152 | K162051 | 000 |
| 04589700010145 | K162051 | 000 |
| 04589700010138 | K162051 | 000 |
| 04589700010121 | K162051 | 000 |
| 04589700010015 | K162051 | 000 |