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ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS AND IRREGULAR COR ENI-EYE SH SOFT K TORIC S

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K122220
510(k) Type
Traditional
Applicant
SOFLEX LIMITED
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/19/2013
Days to Decision
237 days
Submission Type
Statement

ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS AND IRREGULAR COR ENI-EYE SH SOFT K TORIC S

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K122220
510(k) Type
Traditional
Applicant
SOFLEX LIMITED
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/19/2013
Days to Decision
237 days
Submission Type
Statement