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510(k) K991125

SAUFLON AEROTAB DISINFECTING SYSTEM FOR THE DISINFECTION OF SOFT (HYDROPHILIC) CONTACT LENSES by Sauflon Pharmaceuticals, Ltd. — Product Code LPN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1999
Date Received
April 2, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Soft Lens Products
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type

Other clearances by Sauflon Pharmaceuticals, Ltd.

  • K133740 — SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULT (March 5, 2014)
  • K130342 — SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER (August 5, 2013)
  • K130331 — SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT (July 26, 2013)
  • K130734 — SAUFLON MULTIPURPOSE SOLUTION (May 15, 2013)
  • K052832 — SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS (May 15, 2006)
  • K052809 — SAUFLON FLAT COLOURED LENS CASE (November 2, 2005)
  • K033656 — SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE (February 2, 2004)
  • K030278 — SAUFLON MULTIPURPOSE SOLUTION - NO RUB (July 30, 2003)
  • K013649 — SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS (December 26, 2001)
  • K010559 — SAUFLON MULTI LENS CARE SYSTEM (December 20, 2001)

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