The following data is part of a premarket notification filed by Adhezion Biomedical, Llc with the FDA for Surgiseal Topical Skin Adhesive, Surgiseal Stylus Topical Skin Adhesive, Surgiseal Twist Topical Skin Adhesive.
| Device ID | K161011 |
| 510k Number | K161011 |
| Device Name: | SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive |
| Classification | Tissue Adhesive For The Topical Approximation Of Skin |
| Applicant | Adhezion Biomedical, LLC One Meridian Boulevard, Suite 1B02 Wyomissing, PA 19610 |
| Contact | Richard Jones |
| Correspondent | Richard Jones Adhezion Biomedical, LLC One Meridian Boulevard, Suite 1B02 Wyomissing, PA 19610 |
| Product Code | MPN |
| CFR Regulation Number | 878.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-11 |
| Decision Date | 2016-11-08 |
| Summary: | summary |