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510(k) K813429

Device
LASER PHOTOCOAGULATOR ARGON MED. LASER
Applicant
AMERICAN LASER CORP.
510(k) number
K813429
Product code
HPJ  
Decision
Substantially Equivalent (SESE)
Decision date
1982-01-22
Date received
1981-12-08
Regulation
886.1360
Classification name
Instrument, Visual Field, Laser
Medical specialty
Ophthalmic
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

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

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HPJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K864012IRAS PERIMETERRandwal Instrument Co., Inc.1986-12-12
K853556LASER IRASRandwal Instrument Co., Inc.1985-11-01
K822415THE OCUPLOT DCoherent Medical Division1982-09-07
K781507RETINOMETERCoburn Optical Ind., Inc.1978-11-15

Legacy Summary#

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FDA Review#

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