Magnet, Permanent

Device Code: 4281

Product Code(s): HPN

Device Classification Information

Device Type ID4281
Device NameMagnet, Permanent
Regulation DescriptionPermanent Magnet.
Regulation Medical SpecialtyOphthalmic
Review PanelOphthalmic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED)
Diagnostic And Surgical Devices Branch (DSDB)
Submission Type510(K) Exempt
CFR Regulation Number886.4445 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHPN
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4281
DeviceMagnet, Permanent
Product CodeHPN
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionPermanent Magnet.
CFR Regulation Number886.4445 [🔎]
TPLC Last Update: 2019-04-02 20:46:03

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