The following data is part of a premarket notification filed by Avery Dennison Corporation with the FDA for Reliatect Post-op Dressing With Chg (8cm X 15cm), Reliatect Post-op Dressing With Chg (10cm X 25cm).
| Device ID | K163529 |
| 510k Number | K163529 |
| Device Name: | ReliaTect Post-Op Dressing With CHG (8cm X 15cm), ReliaTect Post-Op Dressing With CHG (10cm X 25cm) |
| Classification | Dressing, Wound, Drug |
| Applicant | AVERY DENNISON CORPORATION 7100 Lindsay Dr Bldg 14 Mentor, OH 44060 |
| Contact | Lisa Bartakovics |
| Correspondent | Lisa Bartakovics AVERY DENNISON CORPORATION 7100 Lindsay Dr Bldg 14 Mentor, OH 44060 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-12-16 |
| Decision Date | 2017-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20817138010511 | K163529 | 000 |
| 10817138010507 | K163529 | 000 |