FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING
K Number: K003134
·
Decision Dec 22, 2000
Classifications
1
FEI Numbers
134
Registration Numbers
134
Same Product Code
187
Applicant Total
3
Review Days
77
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING
- K Number
- K003134
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Adri/Technam
- Date Received
- October 6, 2000
- Decision Date
- December 22, 2000
- Product Code
- KGN
- 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 |
|---|---|---|---|
| KGN | Wound Dressing With Animal-Derived Material(S) | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGN), ordered by most recent decision date.
ECMT-100 WMD
FDA 510(k)
FDA Unclassified
·Unknown
Catalyze
FDA 510(k)
FDA Unclassified
·Unknown
Roosin Collagen Dressing
FDA 510(k)
FDA Unclassified
·Unknown
Roosin Collagen Powder
FDA 510(k)
FDA Unclassified
·Unknown
MatriDerm
FDA 510(k)
FDA Unclassified
·Unknown
Derma-Gide
FDA 510(k)
FDA Unclassified
·Unknown