510(k) K100905
K100905 is an FDA 510(k) premarket notification submitted by Mimedx Group, Inc. for the device "HYDROFIX SURGICAL SHEET". The FDA issued a decision of Substantially Equivalent on June 2, 2010. The device falls under product code OMR (Vessel Guard Or Cover), a Class II device regulated under 21 CFR 870.3470. Mimedx Group, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 2, 2010
- Date Received
- April 1, 2010
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vessel Guard Or Cover
- Device Class
- Class II
- Regulation Number
- 870.3470
- Review Panel
- CV
- Submission Type
These device types do not include devices whose primary purpose is to minimize the incidence or severity of adhesion formation as a result of vascular surgery. Intended to protect vessels from injury during surgery (not to be confused with wraps, patches or covers intended to facilitate revision surgeries). Indicated to wrap, patch, or cover intended to cover blood vessels.