EMPTY DIALYSATE CONTAINER
FDA 510(k) clearance K831689 · decided 1983-08-11
Clearance details
- K-number
- K831689
- Device name
- EMPTY DIALYSATE CONTAINER
- Applicant
- Delmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-05-24
- Decision date
- 1983-08-11
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- FKK
- Device class
- 1
- Regulation number
- 876.4730
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- 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 |
|---|---|---|
| TUBING CLAMP CAT#1000-A (K854512) | Rao Medical Devices, Inc. | 1985-12-02 |
| NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET (K854517) | Travenol Laboratories, S.A. | 1985-12-02 |
| CLAMP, TUBING, LINE (K844121) | Dyn-A-Med Products | 1984-12-17 |
| AMP CAPD UNISPIKE AMINISTRATION SET (K822551) | American Medical Products, Inc. | 1982-10-13 |
| FLOWCLAMP CAT.#1011 & 1012 (K802009) | Pollak (Intl.), Ltd. | 1980-10-31 |
Recalls involving this device
No recalls on record reference this clearance.