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Device | Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil |
Generic Name | Lens, contact, orthokeratology, overnight |
Regulation Number | 886.5916 |
Applicant | Euclid Vision Corporation 45472 Holiday Drive Suite 7 Sterling, VA 20166 |
PMA Number | P040029 |
Supplement Number | S019 |
Date Received | 01/14/2021 |
Decision Date | 02/08/2021 |
Product Code |
NUU |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Addition of manufacturing alternatives for the Euclid Systems Orthokeratology (oprifocon A) Toric Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisilfocon A) Toric Contact Lenses for Overnight Wear. |