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510(k) K870257

POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T. by Porex Medical

K870257 is an FDA 510(k) premarket notification submitted by Porex Medical for the device "POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T.". The FDA issued a decision of Substantially Equivalent on February 24, 1987. Porex Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1987
Date Received
January 23, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Porex Medical

  • K872791 — POREX NERVE LOCATOR (October 20, 1987)
  • K873044 — POREX OTOLOGY INSTRUMENTS (September 4, 1987)
  • K872947 — POREX QUALITY PLASTIC SURGERY INSTRUMENTS (August 21, 1987)
  • K863943 — POREX(TM) EYE SPHERE IMPLANT (February 27, 1987)
  • K863946 — POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT (February 27, 1987)
  • K870154 — POREX(TM) TISSUE EXPANDER (February 24, 1987)
  • K870182 — POREX(TM) MALAR IMPLANT (February 24, 1987)
  • K863941 — POREX(TM) PROSTHESIS, CHIN, INTERNAL (October 24, 1986)
  • K863942 — POREX(TM) NOSE PROSTHESIS (October 24, 1986)
  • K863939 — POREX(TM) EAR PROSTHESIS (October 24, 1986)

FDA data resources