510(k) K090206 ยท FRO Dressing, Wound, Drug
OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER
| Applicant | Oculus Innovative Sciences, Inc., Petaluma CA, US |
| Decision | Substantially Equivalent, Jun 2, 2009 |
| Received | Jan 28, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090206
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Oculus Innovative Sciences Inc Microcyn Solution with Preservatives (Rx), 16.9 fl oz (500 mL) and 33.5 fl oz. (990 mL)
Ingredients: Electrolyzed Water (99.97%) Sodium Chloride (NaCl) (230 mg/L) and preservatives: Sodium Hypochlorit Terminated |
FRO | None listed |
| Jan 11, 2012 | Oculus Innovative Sciences Inc Puracyn OTC;
Wound & Skin Care Solution with Preservatives; Sold in 8 fl oz (trigger spray and finder pump) and 16 fl oz pump with insert.
Kills 99.99% of Staph, MRSA, Strep and other Infectious Germ Terminated |
FRO | None listed |
| Jan 11, 2012 | Oculus Innovative Sciences Inc Microcyn Dermatology Spray with germ killing Preservatives (Rx); 8 fl oz.
99.999% Reduction In-solution in 30 seconds.
MRSA - Staphylococcus aureus
VFR - Enterococcus faecalis
Acinetobacter baumannii
Terminated |
FRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.