Ceeon Easysert Intraocular Lens Injector, Model IMP-1
FDA 510(k) K002556 · Pharmacia & Upjohn Co.
510(k) numberK002556
Submission
- Device name
- Ceeon Easysert Intraocular Lens Injector, Model IMP-1
- Applicant
- Pharmacia & Upjohn Co.
Pickerington,, OH, US - Received
- August 17, 2000
- Decision date
- October 31, 2000
- 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 Ceeon Easysert Intraocular Lens Injector, Model IMP-1 cleared by the FDA?
Ceeon Easysert Intraocular Lens Injector, Model IMP-1 (K002556) received a 510(k) decision of Substantially Equivalent on October 31, 2000, 75 days after the submission was received.
What is the product code of K002556?
The FDA product code is MSS – Folders And Injectors, Intraocular Lens (Iol), a Class I (low risk) device regulated under 21 CFR 886.4300.