FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE
K Number: K053613
·
Decision Jul 25, 2007
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
2
Review Days
575
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Basic Information
- Device Name
- L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE
- K Number
- K053613
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Theo Manufacturing BV
- Date Received
- December 27, 2005
- Decision Date
- July 25, 2007
- 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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Other Clearances by Theo Manufacturing BV
| K Number | Device Name | ||
|---|---|---|---|
| K150676 | L-Mesitran Dressing Family II- Soft and Tulle | Dec 23, 2015 | Substantially Equivalent |