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FDA 510(k), K221601, MS-39
FDA 510(k), K221601, MS-39
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510(K) Number: K221601
Device Name: MS-39
Manufacturer: Gilda Mura
Device Classification Name: Tomography, Optical Coherence
Regulation Number: OBO
Classification Product Code: 06/02/2022
Date Received: 09/01/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
Device Name: MS-39
Manufacturer: Gilda Mura
Device Classification Name: Tomography, Optical Coherence
Regulation Number: OBO
Classification Product Code: 06/02/2022
Date Received: 09/01/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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