The following data is part of a premarket notification filed by Care Fusion 213 Llc with the FDA for Chlorashield Tm Antimicrobial Dressing.
| Device ID | K103106 |
| 510k Number | K103106 |
| Device Name: | CHLORASHIELD TM ANTIMICROBIAL DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | CARE FUSION 213 LLC 11400 TOMAHAWK CREEK PARKWAY SUITE 310 Leawood, KS 66211 |
| Contact | Arlen Johnson |
| Correspondent | Arlen Johnson CARE FUSION 213 LLC 11400 TOMAHAWK CREEK PARKWAY SUITE 310 Leawood, KS 66211 |
| 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 | 2010-10-20 |
| Decision Date | 2011-03-30 |
| Summary: | summary |