Turbo-Flow Infusion Cannula 19 GAGE,20 GAGE,23 Gage, 25 Gage, Model 101019,101020,101023,101025
FDA 510(k) K003036 · Retinalabs.Com
510(k) numberK003036
Submission
- Device name
- Turbo-Flow Infusion Cannula 19 GAGE,20 GAGE,23 Gage, 25 Gage, Model 101019,101020,101023,101025
- Applicant
- Retinalabs.Com
Atlanta, GA, US - Received
- September 29, 2000
- Decision date
- December 22, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KYG – Device, Irrigation, Ocular Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4360
- Specialty
- Ophthalmic
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| K954842 | D.O.R.C. Vfi/Vfe SystemKYG · Traditional | Dutch Ophthalmic USA, Inc. | 04/15/1996SE |
| K945171 | Disposable & Resuable Irrigation/Aspiration HandpieceKYG · Traditional | Boston Surgical Products, Inc. | 02/08/1995SE |
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Questions and answers
When was Turbo-Flow Infusion Cannula 19 GAGE,20 GAGE,23 Gage, 25 Gage, Model 101019,101020,101023,101025 cleared by the FDA?
Turbo-Flow Infusion Cannula 19 GAGE,20 GAGE,23 Gage, 25 Gage, Model 101019,101020,101023,101025 (K003036) received a 510(k) decision of Substantially Equivalent on December 22, 2000, 84 days after the submission was received.
What is the product code of K003036?
The FDA product code is KYG – Device, Irrigation, Ocular Surgery, a Class I (low risk) device regulated under 21 CFR 886.4360.