510(k) K781459
- Device
- MONOJECT SCALE MAGNIFIER
- Applicant
- SHERWOOD MEDICAL INDUSTRIES
- 510(k) number
- K781459
- Product code
- HJY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-10-24
- Date received
- 1978-08-23
- Regulation
- 886.5800
- Classification name
- Reader, Bar, Ophthalmic
- 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#
- 8043323
- 3015429108
- 3011321733
- 3007838093
- 3003951061
- 3003047821
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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