U.S. FDA Medical Device Binocular Loupe Requirements
FDA Medical Device Definition: A low-power binocular loupe is a device that consists of two eyepieces, each with a lens or lens system, intended for medical purposes to magnify the appearance of objects.
FDA Binocular Loupe Label Requirements and Exceptions
FDA Binocular Loupe Import Information
FDA Binocular Loupe Detentions (Binocular Loupe Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Binocular Loupe Manufacturers (Binocular Loupe Suppliers)
- Binocular Loupe Distributors
- Binocular Loupe Processors
- Binocular Loupe Repackers
- Binocular Loupe Relabelers
- Binocular Loupe Exporters
- Binocular Loupe Importers
For more information about Binocular Loupe Medical Devices, simply click below:
U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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