MICROCYN WOUND CARE DRESSING
FDA 510(k) clearance K041161 · decided 2005-05-03
Clearance details
- K-number
- K041161
- Device name
- MICROCYN WOUND CARE DRESSING
- Applicant
- Oculus Innovative Sciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-05-03
- Decision date
- 2005-05-03
- Days to decision
- 365 days
- Clearance type
- Traditional
- Product code
- FRO
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Petaluma, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Microcyn Solution with Preservatives (Rx), 16.9 fl oz (500 mL) and 33.5 fl oz. (990 mL) In recall (Z-0448-2012) | Oculus Innovative Sciences Inc | 2012-01-11 |
| Microcyn Dermatology Spray with germ killing Preservatives (Rx); 8 fl oz. 99.999% Reductio recall (Z-0450-2012) | Oculus Innovative Sciences Inc | 2012-01-11 |