510(k) K133542
K133542 is an FDA 510(k) premarket notification submitted by Innovacyn, Inc. for the device "PURACYN PLUS SKIN AND WOUND". The FDA issued a decision of Substantially Equivalent on April 28, 2014. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Innovacyn, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 2014
- Date Received
- November 18, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type