The following data is part of a premarket notification filed by Adhezion Biomedical, Llc with the FDA for Surgiseal Twist (tm) Topical Skin Adhesive.
| Device ID | K133963 |
| 510k Number | K133963 |
| Device Name: | SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE |
| Classification | Tissue Adhesive For The Topical Approximation Of Skin |
| Applicant | Adhezion Biomedical, LLC ONE MERIDIAN BLVD. SUITE 1B02 Wyomissing, PA 19610 |
| Contact | Caridad Smith |
| Correspondent | Caridad Smith Adhezion Biomedical, LLC ONE MERIDIAN BLVD. 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 | 2013-12-24 |
| Decision Date | 2014-09-09 |
| Summary: | summary |