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510(k) K772168

Device
MOLDEYE
Applicant
ROBERT B. SCOTT OCULARISTS OF FLORIDA, INC.
510(k) number
K772168
Product code
HQN  
Decision
Substantially Equivalent (SESE)
Decision date
1977-11-30
Date received
1977-11-08
Regulation
886.3130
Classification name
Conformer, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K945110KOLBERG OPHTHALMIC CONFORMERKolberg Ocular Products, Inc.1995-01-13
K921221STERILE/SINGLE USE SYMBLEPHARON RINGStorz Instrument Co.1992-07-17
K921229STERILE/SINGLE USE OPHTHALMIC CONFORMERSStorz Instrument Co.1992-06-09

Legacy Summary#

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FDA Review#

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