Boston(R) 7 - 30(Enflufocon a)

• • Terminated Z-1705-2010 FDA Unclassified (pre-2012) ·initiated 20 Apr 2010

  The amount of D&C #6 Dye added to the formulation exceeded specified amounts.

510(k) Number

K943177 ↗

FDA Product Code

HQD

Device Class

Class II

Regulation

21 CFR Part 886.5916

Advisory Committee

Ophthalmic

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

• Embedding Ring

  Class I

  FDA 510(k) K831922 Active Cleared 29 Jul 1983

• Boston Es Multivision (Enflufocon a) Contact Lens

  Class II

  FDA 510(k) K970698 Active Cleared 6 May 1997

See all devices from Polymer Technology Corp. →