POR · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5440
Classification
FDA Product Code
POR
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 880.5440
Review panel
HO
Medical specialty
General Hospital
Submission type
7
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm . This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.