The following data is part of a premarket notification filed by Research Instruments Ltd. with the FDA for Saturn 5 Laser.
| Device ID | K141434 |
| 510k Number | K141434 |
| Device Name: | SATURN 5 LASER |
| Classification | System, Assisted Reproduction Laser |
| Applicant | RESEARCH INSTRUMENTS LTD. BICKLAND WATER INDUSTRIAL PARK Falmouth Cornwall, GB Tr 11 4ta |
| Contact | David Landsdowne |
| Correspondent | David Landsdowne RESEARCH INSTRUMENTS LTD. BICKLAND WATER INDUSTRIAL PARK Falmouth Cornwall, GB Tr 11 4ta |
| Product Code | MRX |
| CFR Regulation Number | 884.6200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-30 |
| Decision Date | 2015-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060488044915 | K141434 | 000 |
| 05060488042713 | K141434 | 000 |
| 05060488042706 | K141434 | 000 |
| 05060488042690 | K141434 | 000 |
| 05060488042683 | K141434 | 000 |
| 05060488042676 | K141434 | 000 |
| 05060488042669 | K141434 | 000 |
| 05060488042409 | K141434 | 000 |
| 05060488042393 | K141434 | 000 |
| 05060488041747 | K141434 | 000 |
| 05060488041730 | K141434 | 000 |
| 05060488041723 | K141434 | 000 |
| 05060488041716 | K141434 | 000 |
| 05060488041709 | K141434 | 000 |
| 05060488041693 | K141434 | 000 |
| 05060170183793 | K141434 | 000 |
| 05060488042720 | K141434 | 000 |
| 05060488042737 | K141434 | 000 |
| 05060488044847 | K141434 | 000 |
| 05060488044830 | K141434 | 000 |
| 05060488044823 | K141434 | 000 |
| 05060488044816 | K141434 | 000 |
| 05060488043789 | K141434 | 000 |
| 05060488043772 | K141434 | 000 |
| 05060488043635 | K141434 | 000 |
| 05060488043628 | K141434 | 000 |
| 05060488043406 | K141434 | 000 |
| 05060488043338 | K141434 | 000 |
| 05060488043277 | K141434 | 000 |
| 05060488042812 | K141434 | 000 |
| 05060488042768 | K141434 | 000 |
| 05060488042751 | K141434 | 000 |
| 05060488042744 | K141434 | 000 |
| 05060170183786 | K141434 | 000 |