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510(k) K900478

Device
WOODLYN FULL APERTURE TRIAL LENS SET
Applicant
WOODLYN, INC.
510(k) number
K900478
Product code
HPC  
Decision
Substantially Equivalent (SESE)
Decision date
1990-02-21
Date received
1990-02-01
Regulation
886.1405
Classification name
Set, Lens, Trial, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RONALD NIELSEN
Address
2920 Malmo Dr. Arlington Heights IL US 60005 60005

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HPC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K945443BOBES LENS SETBobes S.A.1995-07-19
K951437OTI MODEL TLS-60Oti Medical, LLC1995-04-11
K930195OPHTHALMIC TRIAL LENSESOptimark Accessories and Instruments1994-01-06
K934859CONTACT LENSESArno Intl., Inc.1993-12-21
K930446MARCO TRIAL SETSMarco Ophthalmic, Inc.1993-07-06
K924786BURTON TRIAL LENS SETR.H. Burton Co.1993-04-14
K920571TRIAL LENS SETR.H. Burton Co.1992-05-07
K873907CONFIRMATION TESTSRichmond Products, Inc.1987-12-29
K852056ACC CROSS CYLINDERSAscon Medical Instruments, Ltd.1985-06-05
K843095TRIA LENS SETOptek Medico Co., Ltd.1984-10-05
K841766WOODLYN CLASSIC TRIAL LENS SETWoodlyn, Inc.1984-06-01
K770389LENS SET, MENTOR TRIALCodman & Shurtleff, Inc.1977-03-14

Legacy Summary#

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FDA Review#

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