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510(k) K853808

HARD CONTACT LENS CLEANING & SOAKING SOLUTION by Maurry Biological Co. — Product Code HPX

K853808 is an FDA 510(k) premarket notification submitted by Maurry Biological Co. for the device "HARD CONTACT LENS CLEANING & SOAKING SOLUTION". The FDA issued a decision of Substantially Equivalent on March 11, 1986. The device falls under product code HPX (Lens, Contact (Polymethylmethacrylate)), a Class U device. Maurry Biological Co. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1986
Date Received
September 11, 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 Maurry Biological Co.

  • K861712 — WETTING & SOAKING HARD CONTACT LENS SOLUTION (May 29, 1986)
  • K853809 — DAILY HARD CONTACT LENS CLEANER (March 11, 1986)
  • K853810 — WETTING SOLUTION FOR HARD CONTACT LENSES (December 16, 1985)
  • K853811 — HARD CONTACT LENS SOAKING SOLUTION (December 16, 1985)
  • K853807 — ALL-IN-ONE HARD CONTACT LENS SOLUTION (December 16, 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