The following data is part of a premarket notification filed by Research Instruments Ltd. with the FDA for Saturn Active Laser System.
Device ID | K083208 |
510k Number | K083208 |
Device Name: | SATURN ACTIVE LASER SYSTEM |
Classification | System, Assisted Reproduction Laser |
Applicant | RESEARCH INSTRUMENTS LTD. BICKLAND INDUSTRIAL PARK Falmouth, Cornwall, GB Tr11 4ta |
Product Code | MRX |
CFR Regulation Number | 884.6200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-10-31 |
Decision Date | 2009-08-25 |
Summary: | summary |