510(k) K052674
- Device
- CONTACT LENS OPHTHALMODYNAMOMETER
- Applicant
- MEDITRON, GMBH
- 510(k) number
- K052674
- Product code
- NYK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-05-24
- Date received
- 2005-09-27
- Regulation
- 886.1385
- Classification name
- Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (pmma)
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT N CLARK
- Address
- 13605 W. 7th Ave. Golden CO US 80401 80401
Source Documents#
Legacy Summary#
summary
FDA Review#
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