- Device
- JSZ ORTHOKERATOLOGY CONTACT LENSES FOR OVERNIGHT WEAR
- Applicant
- Euclid Vision Corporation
- PMA number
- P040029
- Supplement
- S001
- Product code
- NUU
- Generic name
- Lens, contact, orthokeratology, overnight
- Decision date
- 2005-10-14
- Decision code
- APPR
- Date received
- 2005-08-29
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A PROTOCOL OF ACCEPTABLE PROCEDURES TO ALLOW ONE OR MORE INDEPENDENT FINISHING LABORATORIES TO MANUFACTURE AND DISTRIBUTE FINISHED RGP CONTACT LENSES FOR OVERNIGHT ORTHOKERATOLOGY MADE FROM LENS BLANKS.