The following data is part of a premarket notification filed by Adhezion Biomedical, Llc with the FDA for Surgiseal Topical Skin Adhesvie.
| Device ID | K150866 |
| 510k Number | K150866 |
| Device Name: | SURGISEAL Topical Skin Adhesvie |
| Classification | Tissue Adhesive For The Topical Approximation Of Skin |
| Applicant | ADHEZION BIOMEDICAL, LLC ONE MERIDIAN BOULEVARD, SUITE 1B02 Wyomissing, PA 19610 |
| Contact | Tracy Lofgren |
| Correspondent | Tracy Lofgren ADHEZION BIOMEDICAL, LLC ONE MERIDIAN BOULEVARD, SUITE 1B02 Wyomissing, PA 19610 |
| Product Code | MPN |
| CFR Regulation Number | 878.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-01 |
| Decision Date | 2015-07-17 |
| Summary: | summary |