Plastic Surgery And Accessories Kit
A plastic surgery and accessories kit is a convenience kit containing a preselected combination of plastic surgery instruments and related accessories packaged together for use in operative procedures. It is classified as FDA Class 1 (lowest risk), regulated under 21 CFR 878.3925, within the General, Plastic Surgery medical specialty. Per the FDA's May 20, 1997 Convenience Kits Interim Regulatory Guidance, this type of convenience kit is under enforcement discretion and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. No special flags apply to this device.
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Basic Information
- Product Code
- FTN
- Device Class
- FDA class 1
- Regulation Number
- 878.3925
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 7
Device Characteristics
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
FEI Numbers
This FDA classification entry is associated with 33 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 33 registration numbers. Click on an entry to view related FDA registrations.