510(k) K833780
- Device
- Capd Prep Kit
- Applicant
- PROFESSIONAL DIALYSIS PRODUCTS
- 510(k) number
- K833780
- Product code
- FKG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-02-09
- Date received
- 1983-10-28
- Regulation
- 876.5820
- Classification name
- Tray, Start/Stop (Including Contents), Dialysis
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3015173212
- 1423537
- 3035642068
- 3007329020
- 3009888344
- 1836161
- 3004519921
- 3017059795
- 1030451
- 2029015
- 3001644167
- 1422634
- 1423395
- 3004111573
- 9680002
- 1420054
- 8030607
- 1643817
- 1824619
- 9616088
- 2433012
- 3010407203
- 1047429
- 1061124
- 1928237
- 3005012805
- 9611024
- 3005595283
- 8040278
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FKG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K925469 | JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT | J.J. Skinner, Inc. | 1995-05-03 |
| K871630 | KITS AND TRAYS FOR DIALYSIS USE | Dove Medical Supplies | 1987-05-26 |
| K802361 | DIALYIS START CARE KIT | Med-Pak Corp. | 1981-01-16 |
| K792207 | PERIDIAL PERITONEAL DIALYSIS TRAY | Cutter Laboratories, Inc. | 1979-12-10 |
| K790353 | ACUTE RENAL DIALYSIS TRAY | Argon Medical Corp. | 1979-04-20 |