The following data is part of a premarket notification filed by Auxogyn, Inc. with the FDA for Eevatm Petri Dish.
| Device ID | K103028 |
| 510k Number | K103028 |
| Device Name: | EEVATM PETRI DISH |
| Classification | Labware, Assisted Reproduction |
| Applicant | AUXOGYN, INC. 1490 O'BRIEN DRIVE SUITE A Menlo Park, CA 94545 |
| Contact | Robert Newman |
| Correspondent | Robert Newman AUXOGYN, INC. 1490 O'BRIEN DRIVE SUITE A Menlo Park, CA 94545 |
| Product Code | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-13 |
| Decision Date | 2011-08-11 |
| Summary: | summary |