MEDLINE COLLAGEN WOUND DRESSING
FDA 510(k) clearance K060456 · decided 2006-06-19
Clearance details
- K-number
- K060456
- Device name
- MEDLINE COLLAGEN WOUND DRESSING
- Applicant
- Medline Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-02-22
- Decision date
- 2006-06-19
- Days to decision
- 117 days
- Clearance type
- Abbreviated
- Product code
- KGN
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Mundelein, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL, recall (Z-1650-2026) | Medline Industries, LP | 2026-03-27 |