Home / 510(k) Clearances / K022723

510(k) K022723

MASTEL 1 FOLDER IMPLANTATION SYSTEM by Mastel Precision, Inc. — Product Code KYB

K022723 is an FDA 510(k) premarket notification submitted by Mastel Precision, Inc. for the device "MASTEL 1 FOLDER IMPLANTATION SYSTEM". The FDA issued a decision of Substantially Equivalent on December 26, 2002. The device falls under product code KYB (Lens, Guide, Intraocular), a Class I device regulated under 21 CFR 886.4300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 2002
Date Received
August 16, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Guide, Intraocular
Device Class
Class I
Regulation Number
886.4300
Review Panel
OP
Submission Type

Other clearances for product code KYB

  • K152357 — MicroSTAAR Injector System Cartridges (October 30, 2015)
  • K081382 — DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 (October 23, 2008)
  • K072985 — DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 (June 20, 2008)
  • K070669 — IOL INJECTOR SET (November 1, 2007)
  • K063155 — MONARCH III IOL DELIVERY SYSTEM (March 27, 2007)
  • K063694 — AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 (March 7, 2007)
  • K032412 — RE-USEABLE MICROSTAAR INJECTOR, MSI-S (June 10, 2004)
  • K001157 — MONARCH II IOL DELIVERY SYSTEM (June 27, 2000)
  • K983129 — DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) (December 4, 1998)
  • K981571 — MONARCH IOL DELIVERY SYSTEM (July 9, 1998)

FDA data resources