The following data is part of a premarket notification filed by Avery Dennison Belgie, Bvba with the FDA for Benehold Chg Transparent Film Dressing (10x12cm) (8.5x12cm) (6.5x7 Cm).
| Device ID | K113836 |
| 510k Number | K113836 |
| Device Name: | BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM) |
| Classification | Dressing, Wound, Drug |
| Applicant | AVERY DENNISON BELGIE, BVBA 20N. WACKER DRIVE SUITE 2240 Chicago, IL 60606 |
| Contact | Jerzy Wojcik |
| Correspondent | Jerzy Wojcik AVERY DENNISON BELGIE, BVBA 20N. WACKER DRIVE SUITE 2240 Chicago, IL 60606 |
| 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 | 2011-12-28 |
| Decision Date | 2012-09-24 |
| Summary: | summary |