DURAGEN PLUS DURAL GRAFT MATRIX
FDA 510(k) clearance K032693 · decided 2003-09-30
Clearance details
- K-number
- K032693
- Device name
- DURAGEN PLUS DURAL GRAFT MATRIX
- Applicant
- Integra Lifesciences Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-09-02
- Decision date
- 2003-09-30
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- GXQ
- Device class
- 2
- Regulation number
- 882.5910
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Planisboro, NJ, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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