U.S. FDA Medical Device Rectal Dilator Requirements
FDA Medical Device Definition: A rectal dilator is a device designed to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function or the passage of an examining instrument.
FDA Rectal Dilator Label Requirements and Exceptions
FDA Rectal Dilator Import Information
FDA Rectal Dilator Detentions (Rectal Dilator Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Rectal Dilator Manufacturers (Rectal Dilator Suppliers)
- Rectal Dilator Distributors
- Rectal Dilator Processors
- Rectal Dilator Repackers
- Rectal Dilator Relabelers
- Rectal Dilator Exporters
- Rectal Dilator Importers
For more information about Rectal Dilator 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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