510(k) K152476
K152476 is an FDA 510(k) premarket notification submitted by Chemence Medical Products, Inc. for the device "Exofin High Viscosity Tissue Adhesive". The FDA issued a decision of Substantially Equivalent on February 9, 2016. The device falls under product code MPN (Tissue Adhesive For The Topical Approximation Of Skin), a Class II device regulated under 21 CFR 878.4010. Chemence Medical Products, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 2016
- Date Received
- August 31, 2015
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tissue Adhesive For The Topical Approximation Of Skin
- Device Class
- Class II
- Regulation Number
- 878.4010
- Review Panel
- SU
- Submission Type
Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).