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Found 3 results
510(k) Data Aggregation
K Number
K992835Device Name
C.S.O. TONOMETER
Manufacturer
CSO
Date Cleared
2000-06-06
(288 days)
Product Code
HKY
Regulation Number
886.1930Why did this record match?
Applicant Name (Manufacturer) :
CSO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A manual device intended to measure intraocular pressure by applanation (applying a small flat disk to the cornea).
Device Description
A manual device intended to measure intraocular pressure by applanation (applying a small flat disk to the cornea).
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K Number
K992836Device Name
SL990, SL980, SL950
Manufacturer
CSO
Date Cleared
1999-11-09
(78 days)
Product Code
HJO
Regulation Number
886.1850Why did this record match?
Applicant Name (Manufacturer) :
CSO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An AC-powered slitlamp biomicroscope is intended . for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment
Device Description
Biomicroscope, Slit Lamp AC Powered
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K Number
K974454Device Name
CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004
Manufacturer
TUCSON MEDICAL CORP.
Date Cleared
1997-12-18
(23 days)
Product Code
OCT
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
TUCSON MEDICAL CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ClearField Anti-Fog Sterile Wipe is intended for use as an agent to keep external viewing surfaces clear of water vapor and condensation.
Device Description
Sterile cloth pre-saturated with 5cc of Anti-Fog solution. Single Use.
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