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510(k) K920861

Device
WOODLYN CLASSIC LENSMETER
Applicant
WOODLYN, INC.
510(k) number
K920861
Product code
HLM  
Decision
Substantially Equivalent (SESE)
Decision date
1992-07-30
Date received
1992-02-25
Regulation
886.1425
Classification name
Instrument, Measuring, Lens, Ac-powered
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HLM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K944022LENSCHEKLeica, Inc.1994-11-17
K940997AL-3300Hoya Corp. USA1994-09-29
K936199AUTOMATIC LENSOMETERCanon USA, Inc.1994-09-28
K930441MARCO STANDARD LENSMETERS 101,201Marco Ophthalmic, Inc.1993-07-06
K930445MARCO LM-770 DIGITAL PROJECTION LENSMETERMarco Ophthalmic, Inc.1993-06-21
K924776BURTON LENSMETER - MODEL 2021R.H. Burton Co.1993-04-05
K924785BURTON RADIUSGAUGE - MODEL 2030R.H. Burton Co.1993-04-05
K924788BURTON LENSMETERR.H. Burton Co.1993-04-05
K884188NIDEK LM-870 AUTOMATIC LENSMETERNidek, Inc.1988-11-23
K862518BAUSCH & LOMB VERTOMETER V-5Bausch & Lomb, Inc.1986-08-11
K861064LM-850 AUTOMATIC LENSMETERNidek, Inc.1986-04-15
K801767DIMENSION I REFRACTION SYSTEMSmr1980-09-16
K791521VERI-VU LENSOMETERIntermedics, Inc.1979-10-30
K782096INSTRUMENTS, OVERREFRACTION SYSTEMZeiss Humphrey System1979-01-26
K781440LENSOMETER MODEL 11Rodenstock Instrument Corp.1978-09-07

Legacy Summary#

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FDA Review#

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