The following data is part of a premarket notification filed by Intl., Inc. with the FDA for Sunivf Dishes.
| Device ID | K080395 |
| 510k Number | K080395 |
| Device Name: | SUNIVF DISHES |
| Classification | Labware, Assisted Reproduction |
| Applicant | INTL., INC. 393 SOUNDVIEW RD. Guilford, CT 06437 |
| Contact | Michael D Cecchi |
| Correspondent | Michael D Cecchi INTL., INC. 393 SOUNDVIEW RD. Guilford, CT 06437 |
| Product Code | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-13 |
| Decision Date | 2008-08-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815965022314 | K080395 | 000 |
| 00815965021829 | K080395 | 000 |
| 00815965021799 | K080395 | 000 |
| 00815965021782 | K080395 | 000 |
| 00815965021737 | K080395 | 000 |