510(k) K113312
K113312 is an FDA 510(k) premarket notification submitted by Patrin Pharma for the device "HY-CHLO(TM)WOUND SCRUB". The FDA issued a decision of Substantially Equivalent on August 21, 2012. The device falls under product code FQH (Lavage, Jet), a Class II device regulated under 21 CFR 880.5475.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 2012
- Date Received
- November 9, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lavage, Jet
- Device Class
- Class II
- Regulation Number
- 880.5475
- Review Panel
- HO
- Submission Type