- Device
- BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES
- Applicant
- Wavetouch Technologies, LLC
- PMA number
- P860040
- Supplement
- S013
- Product code
- LPL
- Generic name
- Lenses, soft contact, daily wear
- Decision date
- 1995-11-27
- Decision code
- APPR
- Date received
- 1995-02-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- 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