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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCONTACLAIR MULTI-PURPOSE SOLUTION
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantEureka Laboratories, Inc.
Chemin Charlemagne
41220 Cellettes 
PMA NumberP910074
Supplement NumberS001
Date Received04/18/1997
Decision Date07/03/1997
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR EXPANDING THE INDICATIONS TO INCLUDE USE WITH SILICONE/ACRYLATE AND FLUOROSILICONE/ACRYLATE RIGID GAS PERMEABLE (RGP) CONTACT LENSES. WHEN USED WITH RGP LENSES, THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME, CONTACLAIR(R) RGP MULTI-PURPOSE SOLUTION, AND IS INDICATED FOR USE IN CLEANING, RINSING, DISINFECTING AND STORING DAILY AND EXTENDED WEAR RGP CONTACT LENSES.
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