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510(k) K874845

Device
MALIS SURGICAL LOUPES
Applicant
VALLEY FORGE SCIENTIFIC CORP.
510(k) number
K874845
Product code
HJH  
Decision
Substantially Equivalent (SESE)
Decision date
1987-12-23
Date received
1987-11-24
Regulation
886.5120
Classification name
Loupe, Binocular, Low Power
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JERRY L MALIS
Address
P.O. Box 925 Valley Forge PA US 19482 19482

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HJH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K863983EXETER OPERATING LOUPEExeter Instruments, Inc.1986-11-10
K830878BINOCULAR LOUPEAlmore Intl., Inc.1983-04-06

Legacy Summary#

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FDA Review#

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