Hyaluronidase

Device Code: 4939

Product Code(s): IBD

Device Classification Information

Device Type ID4939
Device NameHyaluronidase
Regulation DescriptionEnzyme Preparations.
Regulation Medical SpecialtyPathology
Review PanelPathology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number864.4400 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeIBD
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4939
DeviceHyaluronidase
Product CodeIBD
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionEnzyme Preparations.
CFR Regulation Number864.4400 [🔎]
TPLC Last Update: 2019-04-02 20:57:46

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