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510(k) K897021

MARTIN-HENSLEY SEGMENT LENS by Bruce W. Martin O.D. and Edward Hensley — Product Code HPX

K897021 is an FDA 510(k) premarket notification submitted by Bruce W. Martin O.D. and Edward Hensley for the device "MARTIN-HENSLEY SEGMENT LENS". The FDA issued a decision of Substantially Equivalent on June 22, 1990. The device falls under product code HPX (Lens, Contact (Polymethylmethacrylate)), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1990
Date Received
December 19, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact (Polymethylmethacrylate)
Device Class
Class U
Regulation Number
Review Panel
OP
Submission Type

Other clearances for product code HPX

  • K955777 — PMMA CLASIC (May 16, 1996)
  • K940106 — KERATOPLASTY SUTURING LENS (May 25, 1994)
  • K913081 — MULTI-VIEW BIFOCALS (October 23, 1991)
  • K895411 — OPTIKEM PMMA CONTACT LENS (February 27, 1990)
  • K874591 — ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY (May 3, 1988)
  • K865111 — CHARTER HARD CONTACT LENS CLEANING SOLUTION (January 20, 1987)
  • K864343 — BL1 (HARD CONTACT LENS) (November 28, 1986)
  • K863974 — CHARTER LABORATORIES INC. LENS LUBRICANT (November 10, 1986)
  • K862952 — CHARTER WETTING SOLUTION FOR HARD CONTACT LENSES (September 25, 1986)
  • K862811 — AQUALUX LENS CASE (September 3, 1986)

FDA data resources