Embedding Ring

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K831922 ↗

FDA Product Code

KER

Device Class

Class I

Regulation

21 CFR Part 864.3010

Advisory Committee

Pathology

FDA Decision

SESE Substantially Equivalent

• Rigid Gas Permeable Contact Lens

  Class II

  FDA 510(k) K000795 Active Cleared 26 May 2000

• Empty Solution Transfer Container 1000

  Class II

  FDA 510(k) K843523 Active Cleared 16 Oct 1984

• Boston Liquid Enzymatic Cleaner

  Class II

  FDA 510(k) K973217 Active Cleared 24 Nov 1997

• Rigid Gas Permeable Contact Lens Solution

  Class II

  FDA 510(k) K011945 Active Cleared 12 Sep 2001

• Boston Es Multivision (Enflufocon a) Contact Lens

  Class II

  FDA 510(k) K970698 Active Cleared 6 May 1997

• First Choice

  Class II

  FDA 510(k) K912580 Active Cleared 4 Mar 1992

See all devices from Polymer Technology Corp. →