The following data is part of a premarket notification filed by Molnlycke Health Care, Us Llc with the FDA for Mepiseal Soft Silicone Sealant.
| Device ID | K152741 |
| 510k Number | K152741 |
| Device Name: | Mepiseal Soft Silicone Sealant |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | MOLNLYCKE HEALTH CARE, US LLC 5550 PEACHTREE PARKWAY SUITE 500 Norcross, GA 30092 |
| Contact | Megan Bevill |
| Correspondent | Megan Bevill MOLNLYCKE HEALTH CARE, US LLC 5550 PEACHTREE PARKWAY SUITE 500 Norcross, GA 30092 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-23 |
| Decision Date | 2016-01-22 |
| Summary: | summary |