The following data is part of a premarket notification filed by Adhezion Biomedical with the FDA for Surgiseal Topical Skin Adhesive.
| Device ID | K082993 |
| 510k Number | K082993 |
| Device Name: | SURGISEAL TOPICAL SKIN ADHESIVE |
| Classification | Tissue Adhesive For The Topical Approximation Of Skin |
| Applicant | ADHEZION BIOMEDICAL 506 PINE MOUNTAIN RD Hudson, NC 28638 |
| Contact | Richard G Jones |
| Correspondent | Richard G Jones ADHEZION BIOMEDICAL 506 PINE MOUNTAIN RD Hudson, NC 28638 |
| Product Code | MPN |
| CFR Regulation Number | 878.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-07 |
| Decision Date | 2008-12-19 |
| Summary: | summary |