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.
Device ID | K140517 |
510k Number | K140517 |
Device Name: | SURGISEAL TOPICAL SKIN ADHESIVE/SURGISEAL STYLUS 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 | Richard Jones |
Correspondent | Richard Jones Adhezion Biomedical, LLC ONE MERIDIAN BLVD. 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 | 2014-02-28 |
Decision Date | 2014-04-28 |