510(k) K903666
- Device
- OPHTHASONIC A/P III
- Applicant
- TEKNAR, INC.
- 510(k) number
- K903666
- Product code
- HPY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-11-19
- Date received
- 1990-08-14
- Regulation
- 886.4250
- Classification name
- Unit, Electrolysis, Battery-powered, Ophthalmic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHUCK KUHLMANN
- Address
- 267 Wolfner Dr. Fenton MO US 63026 63026
FDA Registration Numbers#
- 3006982887
- 2521877
- 3006550126
- 3017130991
- 3010220595
- 3010351679
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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