COLLEXA
FDA 510(k) clearance K100574 · decided 2010-10-28
Clearance details
- K-number
- K100574
- Device name
- COLLEXA
- Applicant
- Innocoll Pharmaceuticals
- Decision
- Substantially Equivalent
- Date received
- 2010-03-01
- Decision date
- 2010-10-28
- Days to decision
- 241 days
- Clearance type
- Traditional
- Product code
- KGN
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Athlone, Co. Westmeath, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.