ACTIVON TULLE
FDA 510(k) clearance K101118 · decided 2010-12-15
Clearance details
- K-number
- K101118
- Device name
- ACTIVON TULLE
- Applicant
- Calidad Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-04-21
- Decision date
- 2010-12-15
- Days to decision
- 238 days
- Clearance type
- Traditional
- Product code
- FRO
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Kent, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.