FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER
K Number: K865033
·
Decision Jan 12, 1987
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
54
Applicant Total
11
Review Days
20
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Basic Information
- Device Name
- BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER
- K Number
- K865033
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Cox-Uphuff Intl.
- Date Received
- December 23, 1986
- Decision Date
- January 12, 1987
- 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.
Natrelle 133S Tissue Expanders
FDA 510(k)
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MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs
FDA 510(k)
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Mentor CPX 4 PLUS Enhance Breast Tissue Expander
FDA 510(k)
FDA Unclassified
·Unknown
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
Other Clearances by Cox-Uphuff Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K874276 | CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER | Dec 2, 1987 | Substantially Equivalent |
| K874342 | LIGATURE CARRIER/PACKER, HYDROXYLAPATITE | Nov 13, 1987 | Substantially Equivalent |
| K873470 | TEMPLATE | Sep 8, 1987 | Substantially Equivalent |
| K865056 | CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER | May 22, 1987 | Substantially Equivalent |
| K871200 | CUI NASAL SEPTUM BUTTON | Apr 15, 1987 | Substantially Equivalent |
| K854339 | CUI CHIN SIZER | Nov 15, 1985 | Substantially Equivalent |
| K853945 | CUI RHINOPLASTY IMPLANTS | Oct 18, 1985 | Substantially Equivalent |
| K831566 | CUI MAMMARY PROTHESIS SIZER | Aug 12, 1983 | Substantially Equivalent |
| K813394 | DS-7 CLOSED WOUND SUCTION DRAIN SYSTEM | Jan 22, 1982 | Substantially Equivalent |
| K802214 | COS-UPHOFF INT'L DS-5 DRAINAGE SYSTEM | Oct 23, 1980 | Substantially Equivalent |