INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301
FDA 510(k) clearance K072113 · decided 2007-10-10
Clearance details
- K-number
- K072113
- Device name
- INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301
- Applicant
- Integra Lifesciences Corp.
- Decision
- Substantially Equivalent
- Date received
- 2007-08-01
- Decision date
- 2007-10-10
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- KGN
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Plainsboro, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.