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510(k) K873044

POREX OTOLOGY INSTRUMENTS by Porex Medical — Product Code LRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1987
Date Received
August 4, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Ent Manual Surgical
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances by Porex Medical

  • K872791 — POREX NERVE LOCATOR (October 20, 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)
  • K870257 — POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T. (February 24, 1987)
  • K870182 — POREX(TM) MALAR IMPLANT (February 24, 1987)
  • K863939 — POREX(TM) EAR PROSTHESIS (October 24, 1986)
  • K863941 — POREX(TM) PROSTHESIS, CHIN, INTERNAL (October 24, 1986)
  • K863942 — POREX(TM) NOSE PROSTHESIS (October 24, 1986)

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