The following data is part of a premarket notification filed by Research Instruments Ltd. with the FDA for Saturn 3 Laser System.
| Device ID | K060764 |
| 510k Number | K060764 |
| Device Name: | SATURN 3 LASER SYSTEM |
| Classification | System, Assisted Reproduction Laser |
| Applicant | RESEARCH INSTRUMENTS LTD. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Grace Holland |
| Correspondent | Grace Holland RESEARCH INSTRUMENTS LTD. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | MRX |
| CFR Regulation Number | 884.6200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-21 |
| Decision Date | 2007-03-12 |
| Summary: | summary |