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510(k) K955777

PMMA CLASIC by Rand Scientific Corp. — Product Code HPX

K955777 is an FDA 510(k) premarket notification submitted by Rand Scientific Corp. for the device "PMMA CLASIC". The FDA issued a decision of Substantially Equivalent on May 16, 1996. The device falls under product code HPX (Lens, Contact (Polymethylmethacrylate)), a Class U device. Rand Scientific Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1996
Date Received
December 20, 1995
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 Rand Scientific Corp.

  • K963856 — RAND NASAL PACKING (October 18, 1996)
  • K961081 — SPIRIT RIDGE SILICONE CARVING BLOCK (May 22, 1996)
  • K961057 — DURALASTIC SHEETING II (May 16, 1996)
  • K961072 — PEC IMPLANT (April 19, 1996)
  • K961124 — THE NAUTILUS (April 19, 1996)
  • K961071 — THE MAGNUM CHIN IMPLANT (April 19, 1996)
  • K961080 — MEDIAL MALAR IMPLANT (April 19, 1996)
  • K955366 — TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS (March 28, 1996)
  • K952165 — TRANS-AIRE RIGID GAS PERMEABLE CONTACT LENS (June 30, 1995)

Other clearances for product code HPX

  • 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)
  • K862811 — AQUALUX LENS CASE (September 3, 1986)

FDA data resources