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510(k) K801058

Device
ILLUMINATED SPECULUM
Applicant
DESIGNS FOR VISION, INC.
510(k) number
K801058
Product code
FXF  
Decision
Substantially Equivalent (SESE)
Decision date
1980-05-28
Date received
1980-05-06
Regulation
878.1800
Classification name
Speculum, Illuminated
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
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

Legacy Summary#

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FDA Review#

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