CLIRANS TE08 HOLLOW FIBER DIALYZER
FDA 510(k) clearance K823768 · decided 1983-01-08
Clearance details
- K-number
- K823768
- Device name
- CLIRANS TE08 HOLLOW FIBER DIALYZER
- Applicant
- Terumo Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-12-14
- Decision date
- 1983-01-08
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- HRN
- Device class
- 2
- Regulation number
- 886.4170
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Elkton, MD, US
- Third-party review
- No
- Expedited review
- No
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| D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM (K012821) | Dutch Ophthalmic USA, Inc. | 2001-10-22 |
| KEELER CRYO MASTER & PROBES (K992954) | Keeler Instruments, Inc. | 1999-12-21 |
Recalls involving this device
No recalls on record reference this clearance.