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510(k) K841881

EASY EYES TM LENS CARRYING CASE by Eaton Medical Corp. — Product Code HPX

K841881 is an FDA 510(k) premarket notification submitted by Eaton Medical Corp. for the device "EASY EYES TM LENS CARRYING CASE". The FDA issued a decision of Substantially Equivalent on December 3, 1984. The device falls under product code HPX (Lens, Contact (Polymethylmethacrylate)), a Class U device. Eaton Medical Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1984
Date Received
May 7, 1984
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 Eaton Medical Corp.

  • K931718 — SPIRIT SHIELD (September 20, 1993)
  • K921882 — THE CLEANER ACCESSORY (August 25, 1992)
  • K904824 — EASY EYES TM CONTACT LENS CLEANING MACHINE (July 5, 1991)
  • K871741 — EASY EYES TM LENS CARRYING CASE (July 22, 1987)

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