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ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

Page Type
Cleared 510(K)
510(k) Number
K122213
510(k) Type
Traditional
Applicant
SOFLEX LIMITED
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/12/2012
Days to Decision
140 days
Submission Type
Statement

ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

Page Type
Cleared 510(K)
510(k) Number
K122213
510(k) Type
Traditional
Applicant
SOFLEX LIMITED
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/12/2012
Days to Decision
140 days
Submission Type
Statement