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510(k) K870154

POREX(TM) TISSUE EXPANDER by Porex Medical — Product Code LCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1987
Date Received
January 13, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tissue Expander And Accessories
Device Class
Class U
Regulation Number
Review Panel
SU
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)
  • K863946 — POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT (February 27, 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)
  • K863942 — POREX(TM) NOSE PROSTHESIS (October 24, 1986)
  • K863941 — POREX(TM) PROSTHESIS, CHIN, INTERNAL (October 24, 1986)
  • K863939 — POREX(TM) EAR PROSTHESIS (October 24, 1986)

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