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510(k) K974635

PARAGON LENS CARE by Paragon Vision Sciences — Product Code LRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1998
Date Received
December 12, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Case, Contact Lens
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type

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  • K013310 — PVS BASIC 2; EPIC 2 (April 25, 2002)
  • K010109 — FLUOROPERM 151-OK, PARAGON HDS 100-OK (February 28, 2001)
  • K002845 — PAFLUFOCON C AND E DAILY CONTACT LENS (December 8, 2000)
  • K993586 — SPORTSIGHT GP (May 22, 2000)

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