FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Natrelle 133 Plus Tissue Expander
K Number: K143354
·
Decision Aug 20, 2015
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
54
Applicant Total
33
Review Days
269
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Basic Information
- Device Name
- Natrelle 133 Plus Tissue Expander
- K Number
- K143354
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Allergan, Inc.
- Date Received
- November 24, 2014
- Decision Date
- August 20, 2015
- Product Code
- LCJ
- 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 |
|---|---|---|---|
| LCJ | Tissue Expander And Accessories | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LCJ), ordered by most recent decision date.
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Mentor CPX 4 PLUS Enhance Breast Tissue Expander
FDA 510(k)
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MENTOR CPX4 PLUS Enhance Breast Tissue Expander
FDA 510(k)
FDA Unclassified
·Unknown
Motiva Flora SmoothSilk Tissue Expander
FDA 510(k)
FDA Unclassified
·Unknown
AlloX2 Pro Tissue Expanders
FDA 510(k)
FDA Unclassified
·Unknown
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