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510(k) K945110

Device
KOLBERG OPHTHALMIC CONFORMER
Applicant
KOLBERG OCULAR PRODUCTS, INC.
510(k) number
K945110
Product code
HQN  
Decision
Substantially Equivalent (SESE)
Decision date
1995-01-13
Date received
1994-10-18
Regulation
886.3130
Classification name
Conformer, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
THOMAS J MULDOON
Address
9663 Tierra Grande St., Suite 201 San Diego CA US 92126 92126

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HQN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K972034MEDPOR OCULAR CONFORMERPorex Surgical, Inc.1998-01-20
K970318OCULAR CONFORMERSouthwest Artificial Eyes, Inc.1997-07-07
K970319OCULAR CONFORMERXavier A. Guerra, Ocularist, Inc.1997-07-07
K921221STERILE/SINGLE USE SYMBLEPHARON RINGStorz Instrument Co.1992-07-17
K921229STERILE/SINGLE USE OPHTHALMIC CONFORMERSStorz Instrument Co.1992-06-09
K772168MOLDEYERobert B. Scott Ocularists of Florida, Inc.1977-11-30

Legacy Summary#

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FDA Review#

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