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510(k) K851497

MARLIN CONTACT LENS CASE by Marlin Industries — Product Code HPX

K851497 is an FDA 510(k) premarket notification submitted by Marlin Industries for the device "MARLIN CONTACT LENS CASE". The FDA issued a decision of Substantially Equivalent on May 16, 1985. The device falls under product code HPX (Lens, Contact (Polymethylmethacrylate)), a Class U device. Marlin Industries has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1985
Date Received
April 15, 1985
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 by Marlin Industries

  • K850983 — MARLIN SOFT LENS TWEEZER (September 10, 1985)
  • K850984 — MARLIN SOFT LENS HANDLER (September 10, 1985)

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)
  • K897021 — MARTIN-HENSLEY SEGMENT LENS (June 22, 1990)
  • 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)

FDA data resources