510(k) K841293
- Device
- PANORAMIC LOUPES - VARIOUS
- Applicant
- KELLER INSTRUMENTS, INC.
- 510(k) number
- K841293
- Product code
- HLT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-05-09
- Date received
- 1984-03-29
- Regulation
- 886.1640
- Classification name
- Preamplifier, Ac-powered, Ophthalmic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1221363
- 3008058195
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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