# FDA 483 - Moon Surgical - Unknown Date

Source: https://www.keypedia.com/records/483/moon-surgical/49b7714a-0511-401b-ab44-221cc1982099

> FDA 483 for Moon Surgical on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Moon Surgical
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: This document is a 510(k) premarket notification clearance letter issued to Moon Surgical for their Maestro System (REF100). The FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing Moon Surgical to market it subject to general controls. The letter outlines regulatory requirements and contact information for further questions.

## Related Officers

- [Mark Trumbore](https://www.keypedia.com/people/mark-trumbore/44f28ea0-b3b4-4212-a558-eff9a88b2067)
- [Arian Arab](https://www.keypedia.com/people/arian-arab/ee9da854-ff3a-418a-8b34-b2ec4ace7762)
- [Michelle Shah](https://www.keypedia.com/people/michelle-shah/6272ef24-e3bc-4ba5-99cf-d0a598f902ec)
- [Francisco Delgado](https://www.keypedia.com/people/francisco-delgado/21e945fa-21db-4715-aa3e-8d10df911a68)

Company: https://www.keypedia.com/companies/moon-surgical/857adc09-130a-4e01-992d-58abda6b455f

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4