COIL DIALYSIS, MODELS DM-360 AND DM-360-
FDA 510(k) clearance K790382 · decided 1979-05-02
Clearance details
- K-number
- K790382
- Device name
- COIL DIALYSIS, MODELS DM-360 AND DM-360-
- Applicant
- Estracorporeal, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-02-27
- Decision date
- 1979-05-02
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- FKD
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.