FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
MCGHAN TISSUE EXPANDER FILL KIT
K Number: K853014
·
Decision Sep 18, 1985
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
54
Applicant Total
14
Review Days
63
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Basic Information
- Device Name
- MCGHAN TISSUE EXPANDER FILL KIT
- K Number
- K853014
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Mcghan Medical Corp.
- Date Received
- July 17, 1985
- Decision Date
- September 18, 1985
- 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
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MENTOR CPX4 PLUS Enhance Breast Tissue Expander
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FDA Unclassified
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Motiva Flora SmoothSilk Tissue Expander
FDA 510(k)
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AlloX2 Pro Tissue Expanders
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Mcghan Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K873476 | MINI-MOTOR HAND ENGINE & ACCESS. DERMABRASION BURS | Sep 11, 1987 | Substantially Equivalent |
| K873475 | MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS | Sep 11, 1987 | Substantially Equivalent |
| K870754 | MCGHAN TISSUE EXPANDER FILL SYSTEM | Mar 31, 1987 | Substantially Equivalent |
| K864184 | MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGN | Dec 24, 1986 | Substantially Equivalent |
| K864185 | MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGN | Dec 24, 1986 | Substantially Equivalent |
| K862203 | MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER | Jul 23, 1986 | Substantially Equivalent |
| K854794 | MCGHAN INTEGRAL VALVE TISSUE EXPANDER | Dec 24, 1985 | Substantially Equivalent |
| K843704 | MCGHAN TISSUE EXPANDER | Oct 31, 1984 | Substantially Equivalent |
| K781087 | MEDICAL GRADE SILICONE ELASTOMER TUBING | Nov 22, 1978 | Substantially Equivalent |
| K781700 | IONOTPHORETIC APPLICATOR | Nov 3, 1978 | Substantially Equivalent |