The following data is part of a premarket notification filed by Intl., Inc. with the FDA for Micromanipulation Media System, Lg Hyaluronidase And Lg Paraffin Oil.
| Device ID | K053551 |
| 510k Number | K053551 |
| Device Name: | MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL |
| Classification | Media, Reproductive |
| 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 | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-12-20 |
| Decision Date | 2006-05-09 |