IODOFLEX
FDA 510(k) clearance K190756 · decided 2019-12-20
Clearance details
- K-number
- K190756
- Device name
- IODOFLEX
- Applicant
- Smith & Nephew Medical, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-03-25
- Decision date
- 2019-12-20
- Days to decision
- 270 days
- Clearance type
- Traditional
- Product code
- FRO
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Hull East Riding Of Yorkshire, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.