510(k) K830774
- Device
- BINOCULAR MAGNIFIER 2X
- Applicant
- ALMORE INTL., INC.
- 510(k) number
- K830774
- Product code
- HKC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-04-06
- Date received
- 1983-03-11
- Regulation
- 886.5540
- Classification name
- Spectacle Microscope, Low-vision
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- 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#
- 3009275598
- 3002858762
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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