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 |