REACTION SYSTEM
FDA 510(k) clearance K090221 · decided 2009-07-01
Clearance details
- K-number
- K090221
- Device name
- REACTION SYSTEM
- Applicant
- Viora , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-01-30
- Decision date
- 2009-07-01
- Days to decision
- 152 days
- Clearance type
- Traditional
- Product code
- NUV
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Jersey City, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.