Clirans TE08 Hollow Fiber Dialyzer
FDA 510(k) K823768 · Terumo Medical Corp.
510(k) numberK823768
Submission
- Device name
- Clirans TE08 Hollow Fiber Dialyzer
- Applicant
- Terumo Medical Corp.
Elkton, MD, US - Received
- December 14, 1982
- Decision date
- January 8, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HRN – Unit, Cryophthalmic, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4170
- Specialty
- Ophthalmic
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| K062412 | CryomaticHRN · Traditional | Keeler Instruments, Inc. | 11/06/2006SE |
| K012821 | D.O.R.C. Cryostar Cryosurgical SystemHRN · Traditional | Dutch Ophthalmic USA, Inc. | 10/22/2001SE |
| K992954 | Keeler Cryo Master & ProbesHRN · Traditional | Keeler Instruments, Inc. | 12/21/1999SE |
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Questions and answers
When was Clirans TE08 Hollow Fiber Dialyzer cleared by the FDA?
Clirans TE08 Hollow Fiber Dialyzer (K823768) received a 510(k) decision of Substantially Equivalent on January 8, 1983, 25 days after the submission was received.
What is the product code of K823768?
The FDA product code is HRN – Unit, Cryophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4170.