PERIDIAL PERITONEAL DIALYSIS TRAY
FDA 510(k) clearance K792207 · decided 1979-12-10
Clearance details
- K-number
- K792207
- Device name
- PERIDIAL PERITONEAL DIALYSIS TRAY
- Applicant
- Cutter Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-11-02
- Decision date
- 1979-12-10
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- FKG
- Device class
- 1
- 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT (K925469) | J.J. Skinner, Inc. | 1995-05-03 |
| KITS AND TRAYS FOR DIALYSIS USE (K871630) | Dove Medical Supplies | 1987-05-26 |
| CAPD PREP KIT (K833780) | Professional Dialysis Products | 1984-02-09 |
| DIALYIS START CARE KIT (K802361) | Med-Pak Corp. | 1981-01-16 |
| ACUTE RENAL DIALYSIS TRAY (K790353) | Argon Medical Corp. | 1979-04-20 |
Recalls involving this device
No recalls on record reference this clearance.