The following data is part of a premarket notification filed by Avery Dennison Belgie Bvba with the FDA for Benehold Surgical Incise Drape With Chg Antimicrobial.
| Device ID | K202208 |
| 510k Number | K202208 |
| Device Name: | BeneHold Surgical Incise Drape With CHG Antimicrobial |
| Classification | Drape, Surgical |
| Applicant | Avery Dennison Belgie BVBA Tieblokkenlaan, 1 Turnhout, BE 2300 |
| Contact | Lisa Bartakovics |
| Correspondent | Lisa Bartakovics Avery Dennison Belgie BVBA Tieblokkenlaan, 1 Turnhout, BE 2300 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-06 |
| Decision Date | 2021-07-30 |