The following data is part of a premarket notification filed by Bergen Medical Products, Inc. with the FDA for Actabond Topical Skin Adhesive.
| Device ID | K161050 |
| 510k Number | K161050 |
| Device Name: | ACTABOND Topical Skin Adhesive |
| Classification | Tissue Adhesive For The Topical Approximation Of Skin |
| Applicant | BERGEN MEDICAL PRODUCTS, INC. 16 WING DRIVE Cedar Knolls, NJ 07927 |
| Contact | Tom Stephens |
| Correspondent | Tom Stephens BERGEN MEDICAL PRODUCTS, INC. 16 WING DRIVE Cedar Knolls, NJ 07927 |
| Product Code | MPN |
| CFR Regulation Number | 878.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-14 |
| Decision Date | 2016-10-04 |
| Summary: | summary |