The following data is part of a premarket notification filed by Molnlycke Health Care, Us Llc with the FDA for Avance Gauze Dressing Kits.
Device ID | K161948 |
510k Number | K161948 |
Device Name: | Avance Gauze Dressing Kits |
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 | Yes |
Date Received | 2016-07-15 |
Decision Date | 2016-11-03 |
Summary: | summary |