The following data is part of a premarket notification filed by Adhezion Biomedical, Llc with the FDA for Surgiseal Topical Skin Adhesive.
| Device ID | K130474 |
| 510k Number | K130474 |
| Device Name: | SURGISEAL TOPICAL SKIN ADHESIVE |
| Classification | Tissue Adhesive For The Topical Approximation Of Skin |
| Applicant | Adhezion Biomedical, LLC ONE MERIDIAN PARKWAY SUITE 1B02 Wyomissing, PA 19610 |
| Contact | Caridad Smith |
| Correspondent | Caridad Smith Adhezion Biomedical, LLC ONE MERIDIAN PARKWAY SUITE 1B02 Wyomissing, PA 19610 |
| Product Code | MPN |
| CFR Regulation Number | 878.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-25 |
| Decision Date | 2013-05-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00304040178850 | K130474 | 000 |