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510(k) K003933

BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY by Polymer Technology — Product Code MUW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2001
Date Received
December 20, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact (Orthokeratology)
Device Class
Class II
Regulation Number
886.5916
Review Panel
OP
Submission Type

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