510(k) K133963
K133963 is an FDA 510(k) premarket notification submitted by Adhezion Biomedical, LLC for the device "SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE". The FDA issued a decision of Substantially Equivalent on September 9, 2014. 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. Adhezion Biomedical, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 2014
- Date Received
- December 24, 2013
- Clearance Type
- Special
- 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).