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510(k) K003933

Device
BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY
Applicant
POLYMER TECHNOLOGY
510(k) number
K003933
Product code
MUW  
Decision
Substantially Equivalent (SESE)
Decision date
2001-02-16
Date received
2000-12-20
Regulation
886.5916
Classification name
Lens, Contact (orthokeratology)
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
NANCY ABRAHAM
Address
1400 N. Goodman St. Rochester NY US 14603 14603

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MUW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K183200iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact LensesC&E GP Specialist, Inc.2019-01-09
K160859OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)Contamac, Ltd.2016-07-13
K010109FLUOROPERM 151-OK, PARAGON HDS 100-OKParagon Vision Sciences2001-02-28
K000224FLUROPERM 60-OK, PARAGON HDS-OKParagon Vision Sciences2000-04-17
K973697AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGYAirperm, Inc.1998-04-08

Legacy Summary#

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FDA Review#

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