The following data is part of a premarket notification filed by Convatec Limited with the FDA for Avelle Negative Pressure Wound Therapy System.
| Device ID | K180205 |
| 510k Number | K180205 |
| Device Name: | AVELLE Negative Pressure Wound Therapy System |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | ConvaTec Limited First Avenue Deeside, GB Ch5 2nu |
| Contact | Justin Lovelace |
| Correspondent | Justin Lovelace ConvaTec Limited First Avenue Deeside, GB Ch5 2nu |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-24 |
| Decision Date | 2018-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00768455155040 | K180205 | 000 |
| 00768455154357 | K180205 | 000 |
| 00768455154340 | K180205 | 000 |
| 00768455154333 | K180205 | 000 |
| 00768455148905 | K180205 | 000 |
| 00768455148899 | K180205 | 000 |
| 00768455148882 | K180205 | 000 |
| 00768455148875 | K180205 | 000 |