The following data is part of a premarket notification filed by Bio-medical Carbon Technology Co., Ltd. with the FDA for Bct Antimicrobial Dressing & Bct Silver Bandage.
| Device ID | K140147 |
| 510k Number | K140147 |
| Device Name: | BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGE |
| Classification | Dressing, Wound, Drug |
| Applicant | BIO-MEDICAL CARBON TECHNOLOGY CO., LTD. 816 CONGRESS AVE. STE 1400 Austin, TX 78701 |
| Contact | Diane Sudduth |
| Correspondent | Diane Sudduth BIO-MEDICAL CARBON TECHNOLOGY CO., LTD. 816 CONGRESS AVE. STE 1400 Austin, TX 78701 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-22 |
| Decision Date | 2014-04-22 |
| Summary: | summary |