FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
POREX(TM) TISSUE EXPANDER
K Number: K870154
·
Decision Feb 24, 1987
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
54
Applicant Total
15
Review Days
42
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Basic Information
- Device Name
- POREX(TM) TISSUE EXPANDER
- K Number
- K870154
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Porex Medical
- Date Received
- January 13, 1987
- Decision Date
- February 24, 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 |
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AlloX2 Pro Tissue Expanders
FDA 510(k)
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Other Clearances by Porex Medical
| K Number | Device Name | ||
|---|---|---|---|
| K872791 | POREX NERVE LOCATOR | Oct 20, 1987 | Substantially Equivalent |
| K873044 | POREX OTOLOGY INSTRUMENTS | Sep 4, 1987 | Substantially Equivalent |
| K872947 | POREX QUALITY PLASTIC SURGERY INSTRUMENTS | Aug 21, 1987 | Substantially Equivalent |
| K863943 | POREX(TM) EYE SPHERE IMPLANT | Feb 27, 1987 | Substantially Equivalent |
| K863946 | POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT | Feb 27, 1987 | Substantially Equivalent |
| K870182 | POREX(TM) MALAR IMPLANT | Feb 24, 1987 | Substantially Equivalent |
| K870257 | POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T. | Feb 24, 1987 | Substantially Equivalent |
| K863939 | POREX(TM) EAR PROSTHESIS | Oct 24, 1986 | Substantially Equivalent |
| K863942 | POREX(TM) NOSE PROSTHESIS | Oct 24, 1986 | Substantially Equivalent |
| K863941 | POREX(TM) PROSTHESIS, CHIN, INTERNAL | Oct 24, 1986 | Substantially Equivalent |