FDA.reportPublic FDA data

510(k) K820375

Device
PLASTIC OR GLASS MAGNIFIER
Applicant
GAZELLE CORP.
510(k) number
K820375
Product code
HJF  
Decision
Substantially Equivalent (SESE)
Decision date
1982-06-14
Date received
1982-02-09
Regulation
886.5540
Classification name
Magnifier, Hand-held, Low-vision
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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