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510(k) K865111

CHARTER HARD CONTACT LENS CLEANING SOLUTION by Paco Pharmaceutical Services, Inc. — Product Code HPX

K865111 is an FDA 510(k) premarket notification submitted by Paco Pharmaceutical Services, Inc. for the device "CHARTER HARD CONTACT LENS CLEANING SOLUTION". The FDA issued a decision of Substantially Equivalent on January 20, 1987. The device falls under product code HPX (Lens, Contact (Polymethylmethacrylate)), a Class U device. Paco Pharmaceutical Services, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 1987
Date Received
December 31, 1986
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 Paco Pharmaceutical Services, Inc.

  • K863974 — CHARTER LABORATORIES INC. LENS LUBRICANT (November 10, 1986)
  • K862952 — CHARTER WETTING SOLUTION FOR HARD CONTACT LENSES (September 25, 1986)
  • K843797 — STERILE SALINE SOLUTION (January 18, 1985)
  • K843796 — STERILE WATER (December 10, 1984)
  • K761093 — BANDAGE (January 6, 1977)

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)
  • 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