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#
- 1418300
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HOJ #
Legacy Summary#
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FDA Review#
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