FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
LIQUIBAND ULTIMA, LUT 003
K Number: K100284
·
Decision Apr 9, 2010
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
35
Applicant Total
5
Review Days
67
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Basic Information
- Device Name
- LIQUIBAND ULTIMA, LUT 003
- K Number
- K100284
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4010
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medlogic Global Limited
- Date Received
- February 1, 2010
- Decision Date
- April 9, 2010
- Product Code
- MPN
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| MPN | Tissue Adhesive For The Topical Approximation Of Skin | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Medlogic Global Limited
| K Number | Device Name | ||
|---|---|---|---|
| K110184 | LIQUIBAND FLOW CONTROL | Dec 16, 2011 | Substantially Equivalent |
| K102076 | LIQUIBAND DUAL, MODEL LBD 001 | Feb 18, 2011 | Substantially Equivalent |
| K031321 | LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001 | Jan 21, 2004 | Substantially Equivalent |
| K023163 | LIQUISHIELD-S (0.7G), MODEL LS 0010, LIQUISHIELD-S (2.0G), MODEL LS 0020 | Jan 13, 2003 | Substantially Equivalent |