The following data is part of a premarket notification filed by Avery Dennison Belgie Bvba with the FDA for Bd Chlorashield Iv Dressing With Chg Antimicrobial.
Device ID | K152923 |
510k Number | K152923 |
Device Name: | BD ChloraShield IV Dressing With CHG Antimicrobial |
Classification | Dressing, Wound, Drug |
Applicant | AVERY DENNISON BELGIE BVBA TIEBLOKKENLAAN 1 Turnhout, BE B-2300 |
Contact | Lisa Bartakovics |
Correspondent | Lisa Bartakovics AVERY DENNISON BELGIE BVBA TIEBLOKKENLAAN 1 Turnhout, BE B-2300 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2015-10-05 |
Decision Date | 2015-11-05 |
Summary: | summary |