FDA 510(k)
Substantially Equivalent
🇺🇸 United States
POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T.
K Number: K870257
·
Decision Feb 24, 1987
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
15
Review Days
32
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Basic Information
- Device Name
- POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T.
- K Number
- K870257
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Porex Medical
- Date Received
- January 23, 1987
- Decision Date
- February 24, 1987
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
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 |
| K870154 | POREX(TM) TISSUE EXPANDER | Feb 24, 1987 | Substantially Equivalent |
| K870182 | POREX(TM) MALAR IMPLANT | 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 |