FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN
FDA 510(k) clearance K000054 · decided 2000-03-13
Clearance details
- K-number
- K000054
- Device name
- FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN
- Applicant
- Adri
- Decision
- Substantially Equivalent
- Date received
- 2000-01-07
- Decision date
- 2000-03-13
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- KGN
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Park Forest, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.