MICROCYN SCAR MANAGEMENT HYDROGEL
FDA 510(k) clearance K131672 · decided 2013-11-15
Clearance details
- K-number
- K131672
- Device name
- MICROCYN SCAR MANAGEMENT HYDROGEL
- Applicant
- Oculus Innovative Sciences
- Decision
- Substantially Equivalent
- Date received
- 2013-06-06
- Decision date
- 2013-11-15
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- PFP
- Device class
- 1
- Regulation number
- 878.4025
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Petaluma, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.