FDA 510(k)
FDA unclassified
Substantially Equivalent
🇨🇳 China
ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC
K Number: K233111
·
Decision May 24, 2024
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
3
Review Days
240
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Basic Information
- Device Name
- ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC
- K Number
- K233111
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Foshan United Medical Technologies, Ltd.
- Date Received
- September 27, 2023
- Decision Date
- May 24, 2024
- Product Code
- FRO
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
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