MULTIDEX HYDROPHILIC WOUND DRESSING
FDA 510(k) clearance K945000 · decided 1994-11-17
Clearance details
- K-number
- K945000
- Device name
- MULTIDEX HYDROPHILIC WOUND DRESSING
- Applicant
- Lange Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-10-13
- Decision date
- 1994-11-17
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- KMF
- Device class
- 1
- Regulation number
- 880.5090
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Wheeling, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Multidex Powder, Maltodextrin Wound Dressing, Catalog Numbers: 46-701, 46-702, 46-703, 46- recall (Z-0544-04) | DeRoyal Surgical Tray | 2004-02-24 |