The following data is part of a premarket notification filed by Intl., Inc. with the FDA for Allgrad And Allgrad100.
| Device ID | K022335 |
| 510k Number | K022335 |
| Device Name: | ALLGRAD AND ALLGRAD100 |
| Classification | Media, Reproductive |
| Applicant | INTL., INC. 393 SOUNDVIEW RD. Guilford, CT 06443 |
| Contact | Michael D Cecchi |
| Correspondent | Michael D Cecchi INTL., INC. 393 SOUNDVIEW RD. Guilford, CT 06443 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-18 |
| Decision Date | 2002-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815965020822 | K022335 | 000 |
| 00815965020815 | K022335 | 000 |
| 00815965020808 | K022335 | 000 |