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Dura Substitute

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5910
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.5910 Dura substitute

§ 882.5910 Dura substitute.

(a) Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).

(b) Classification. Class II (performance standards).

Dura Substitute

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5910
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.5910 Dura substitute

§ 882.5910 Dura substitute.

(a) Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).

(b) Classification. Class II (performance standards).