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510(k) K853729

KESTREL CONTACT LENS STORAGE CASE(POLYSTYRENE) by Ryder Intl. Corp. — Product Code HPX

K853729 is an FDA 510(k) premarket notification submitted by Ryder Intl. Corp. for the device "KESTREL CONTACT LENS STORAGE CASE(POLYSTYRENE)". The FDA issued a decision of Substantially Equivalent on December 13, 1985. The device falls under product code HPX (Lens, Contact (Polymethylmethacrylate)), a Class U device. Ryder Intl. Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1985
Date Received
September 6, 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 Ryder Intl. Corp.

  • K962611 — BARD EAGLE INFLATION DEVICE (October 21, 1996)
  • K962151 — RYDER LACRIMAL INTUBATIONSET (September 18, 1996)
  • K953522 — USCI IDEAL PTCA KIT (April 17, 1996)
  • K920064 — OPTI-LENS CONTACT LENS CASE (March 4, 1992)
  • K915082 — OPTI-LENS(TM) CONTACT LENS CASE (January 13, 1992)
  • K881981 — ASSIST(TM) ASEPTIC SYRINGE IRRIGATION SYSTEM (August 2, 1988)
  • K870278 — CONTACT LENS CASE W/POSTIVE HEAT INDI. MOD. #695 (February 20, 1987)
  • K853727 — KESTREL CONTACT LENS STORAGE CASE(POLYSULFONE) (February 7, 1986)
  • K853728 — KESTREL CONTACT LENS STORAGE CASE(NORYL) (December 13, 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