The following data is part of a premarket notification filed by Optmed, Inc. with the FDA for Bondease Topical Skin Adhesive.
| Device ID | K141157 |
| 510k Number | K141157 |
| Device Name: | BONDEASE TOPICAL SKIN ADHESIVE |
| Classification | Tissue Adhesive For The Topical Approximation Of Skin |
| Applicant | OPTMED, INC. 601 LEXINGTON AVENUE SUITE 5100 New York, NY 10022 |
| Contact | Stephanie Rais |
| Correspondent | Stephanie Rais OPTMED, INC. 601 LEXINGTON AVENUE SUITE 5100 New York, NY 10022 |
| Product Code | MPN |
| CFR Regulation Number | 878.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-05 |
| Decision Date | 2015-12-22 |
| Summary: | summary |