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510(k) K862952

CHARTER WETTING SOLUTION FOR HARD CONTACT LENSES by Paco Pharmaceutical Services, Inc. — Product Code HPX

K862952 is an FDA 510(k) premarket notification submitted by Paco Pharmaceutical Services, Inc. for the device "CHARTER WETTING SOLUTION FOR HARD CONTACT LENSES". The FDA issued a decision of Substantially Equivalent on September 25, 1986. 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
September 25, 1986
Date Received
August 5, 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.

  • K865111 — CHARTER HARD CONTACT LENS CLEANING SOLUTION (January 20, 1987)
  • K863974 — CHARTER LABORATORIES INC. LENS LUBRICANT (November 10, 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)
  • 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)
  • K862811 — AQUALUX LENS CASE (September 3, 1986)

FDA data resources