510(k) K822828
- Device
- SOFT LENS THERMAL DISINFECTING UNIT, A-C
- Applicant
- SAFEWAY PRODUCTS, INC.
- 510(k) number
- K822828
- Product code
- HRD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-10-29
- Date received
- 1982-09-21
- Regulation
- 886.5928
- Classification name
- Sterilizer, Soft-lens, Thermal, Ac-powered
- 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
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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