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 |