FDA 510(k) K140147, BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGE, by Bio-Medical Carbon Technology Co., Ltd.
FDA 510(k) K140147, BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGE, by Bio-Medical Carbon Technology Co., Ltd.
FDA 510(k) records for BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGE (K140147), submitted by Bio-Medical Carbon Technology Co., Ltd..
- 510(k) Number: K140147
- Device Classification: Dressing, Wound, Drug
- Applicant: Bio-Medical Carbon Technology Co., Ltd.
- Date Received: 01/22/2014
- Decision Date: 04/22/2014
- Decision: Substantially Equivalent (SESE)
- Regulation Number: nan
- Product Code: FRO
- Regulation Medical Specialty: nan
- Review Panel: General & Plastic Surgery
- Total Pages: 721 (501 unredacted, 30% redacted overall)
What's in this document (sections may appear in any order):
- ~ 510(k) Summary / Statement: 58% redacted
- ~ Indications for Use: 56% redacted
- ~ Device Description: 58% redacted
- ✗ Substantial Equivalence / Predicate: 63% redacted
- ✗ Performance / Bench Testing: 78% redacted
- ✗ Biocompatibility: 69% redacted
- ✗ Software / Cybersecurity: 64% redacted
- ✗ Sterilization / Shelf Life: 76% redacted
- ~ Labeling / IFU: 43% redacted
- ~ Clinical Data: 50% redacted
- ✗ FDA Correspondence: 62% redacted
- ✗ Risk Analysis / FMEA: 75% redacted
- ~ Electromagnetic Compatibility (EMC): 50% redacted
Section contents and redaction percentages are AI-assisted estimates based on automated document analysis. Actual content may vary.
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