Dressing, Compression

Device Code: 5473

Product Code(s): MHW

Device Classification Information

Device Type ID5473
Device NameDressing, Compression
Regulation DescriptionElastic Bandage.
Regulation Medical SpecialtyGeneral Hospital
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1)
Submission Type510(K) Exempt
CFR Regulation Number880.5075 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeMHW
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5473
DeviceDressing, Compression
Product CodeMHW
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionElastic Bandage.
CFR Regulation Number880.5075 [🔎]
Recalls
Manufacturer Recall Class Date Posted
1
Amd Ritmed
II Mar-25-2016
TPLC Last Update: 2019-04-02 21:06:50

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