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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.
 
DeviceBIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES
Generic NameLenses, soft contact, daily wear
Regulation Number886.5925
ApplicantWAVETOUCH TECHNOLOGIES, LLC
15970 BERNARDO CENTER DR.
SAN DIEGO, CA 92127
PMA NumberP860040
Supplement NumberS013
Date Received02/28/1995
Decision Date11/27/1995
Product Code LPL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR RELOCATION OF THE ALTERNATE MANUFACTURER, WESTCON CONTACT LENS CO., FROM 2775 CROSSROADS BOULEVARD, #110, GRAND JUNCTION, CO 81506 TO 611 EISENHAUER STREET, GRAND JUNCTION, CO 81505 AND FOR A CHANGE IN THE STERILIZATION PROCESS TO INCLUDE PARAMETRIC RELEASE AT WESTCON CONTACT LENS CO., 611 EISENHAUER STREET, GRAND JUNCTION, CO 81505 FOR HORIZON 55 SPHERICAL AND HORIZON 55 TORIC (METHAFILCON A) HYDROPHILIC CONTACT LENSES FOR EXTENDED WEAR
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