The following data is part of a premarket notification filed by Molnlycke Health Care, Us Llc with the FDA for Avance Tubing, Avance Y-connector, Avance Viewpad.
| Device ID | K161797 |
| 510k Number | K161797 |
| Device Name: | Avance Tubing, Avance Y-Connector, Avance ViewPad |
| 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 | 2016-06-30 |
| Decision Date | 2016-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07323190160570 | K161797 | 000 |
| 07323190193486 | K161797 | 000 |
| 07323190193448 | K161797 | 000 |
| 07332551585303 | K161797 | 000 |
| 07332551585341 | K161797 | 000 |
| 07332551585150 | K161797 | 000 |
| 07332551581268 | K161797 | 000 |
| 07333350979195 | K161797 | 000 |
| 07333350287719 | K161797 | 000 |
| 07333350575403 | K161797 | 000 |
| 07323190193516 | K161797 | 000 |
| 07323190193530 | K161797 | 000 |
| 07323190160532 | K161797 | 000 |
| 07323190160495 | K161797 | 000 |
| 07323190154432 | K161797 | 000 |
| 07323190154395 | K161797 | 000 |
| 07323190193684 | K161797 | 000 |
| 07323190193660 | K161797 | 000 |
| 07323190193639 | K161797 | 000 |
| 07323190193592 | K161797 | 000 |
| 07323190193578 | K161797 | 000 |
| 07333350579074 | K161797 | 000 |