510(k) K844657

Device
SPECTABLE FRAME MAGNIFYING BRILLETTE
Applicant
PRO DESIGN INTL. AS
510(k) number
K844657
Product code
HOJ  
Decision
Substantially Equivalent (SESE)
Decision date
1984-12-11
Date received
1984-11-29
Regulation
886.1810
Classification name
Screen, Tangent, Target
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LARS KLITBO
Address
20 Waterside Plz. Apt. 31-D New York NY US 10010 10010

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HOJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K873919TANGENT SCREENRichmond Products, Inc.1987-10-28
K821081CHART PROJECTORMedical Equipment Designs, Inc.1982-06-14

Legacy Summary#

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FDA Review#

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