Mport Foldable Lens Placement System
FDA 510(k) K970727 · Chiron Vision Corp.
510(k) numberK970727
Submission
- Device name
- Mport Foldable Lens Placement System
- Applicant
- Chiron Vision Corp.
Claremont, CA, US - Received
- February 28, 1997
- Decision date
- December 17, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSS – Folders And Injectors, Intraocular Lens (Iol)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4300
- Specialty
- Ophthalmic
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Questions and answers
When was Mport Foldable Lens Placement System cleared by the FDA?
Mport Foldable Lens Placement System (K970727) received a 510(k) decision of Substantially Equivalent on December 17, 1997, 292 days after the submission was received.
What is the product code of K970727?
The FDA product code is MSS – Folders And Injectors, Intraocular Lens (Iol), a Class I (low risk) device regulated under 21 CFR 886.4300.