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510(k) K082799

HDS HI 1.54 by Paragon Vision Sciences — Product Code HQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2009
Date Received
September 23, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact (Other Material) - Daily
Device Class
Class II
Regulation Number
886.5916
Review Panel
OP
Submission Type

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