The following data is part of a premarket notification filed by Humagen Fertility Diagnostics, Inc. with the FDA for Newlife Dish (etched Or Non-etched, With Or Without Lid), Models 14-52, 1452e, 1452el, 1452l.
| Device ID | K990941 |
| 510k Number | K990941 |
| Device Name: | NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L |
| Classification | Labware, Assisted Reproduction |
| Applicant | HUMAGEN FERTILITY DIAGNOSTICS, INC. 2400 HUNTER'S WAY Charlottesville, VA 22911 |
| Contact | Cindy Showalter |
| Correspondent | Cindy Showalter HUMAGEN FERTILITY DIAGNOSTICS, INC. 2400 HUNTER'S WAY Charlottesville, VA 22911 |
| Product Code | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-22 |
| Decision Date | 1999-07-14 |
| Summary: | summary |