The following data is part of a premarket notification filed by Avery Dennison Belgie, Bvba with the FDA for Chlorashield Iv Dressing With Chg Antimicrobial.
Device ID | K133764 |
510k Number | K133764 |
Device Name: | 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 | 2013-12-11 |
Decision Date | 2014-03-13 |
Summary: | summary |