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510(k) K930437

Device
MARCO STANDARD RADIUSGAUGES
Applicant
MARCO OPHTHALMIC, INC.
510(k) number
K930437
Product code
HLF  
Decision
Substantially Equivalent (SESE)
Decision date
1993-08-09
Date received
1993-01-26
Regulation
886.1430
Classification name
Device, Measuring, Lens Radius, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
WAYNE STARLING
Address
11825 Central Pkwy. Jacksonville FL US 32224 32224

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HLF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K862517BAUSCH & LOMB CONTACT LENS VIEWERBausch & Lomb, Inc.1986-08-11
K823767ERG-JET ELECTRODELife-Tech Intl., Inc.1983-01-08

Legacy Summary#

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FDA Review#

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