NIKKISO PARALLEL FLOW DIALYZERS
FDA 510(k) clearance K801065 · decided 1980-08-07
Clearance details
- K-number
- K801065
- Device name
- NIKKISO PARALLEL FLOW DIALYZERS
- Applicant
- Int'L Marketing & Sales Corp.
- Decision
- Substantially Equivalent
- Date received
- 1980-05-06
- Decision date
- 1980-08-07
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- FTG
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FITTING/DIALYZER (K760815) | Cobe Laboratories, Inc. | 1976-11-19 |
Recalls involving this device
No recalls on record reference this clearance.