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510(k) K863946

POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT by Porex Medical — Product Code HQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1987
Date Received
October 10, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Orbital, Extra-Ocular
Device Class
Class II
Regulation Number
886.3340
Review Panel
OP
Submission Type

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)
  • K870182 — POREX(TM) MALAR IMPLANT (February 24, 1987)
  • K870257 — POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T. (February 24, 1987)
  • K870154 — POREX(TM) TISSUE EXPANDER (February 24, 1987)
  • K863939 — POREX(TM) EAR PROSTHESIS (October 24, 1986)
  • K863942 — POREX(TM) NOSE PROSTHESIS (October 24, 1986)
  • K863941 — POREX(TM) PROSTHESIS, CHIN, INTERNAL (October 24, 1986)

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