The following data is part of a premarket notification filed by J.j. Skinner, Inc. with the FDA for Jj Skinner Carekits(tm) Dialysis On/off Kit.
| Device ID | K925469 |
| 510k Number | K925469 |
| Device Name: | JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT |
| Classification | Tray, Start/stop (including Contents), Dialysis |
| Applicant | J.J. SKINNER, INC. C/O MEDICAL DEVICE INSPECTION 55 NORTHERN BLVD., SUITE 301 Great Neck, NY 11021 |
| Contact | Carolann Kotula-cook |
| Correspondent | Carolann Kotula-cook J.J. SKINNER, INC. C/O MEDICAL DEVICE INSPECTION 55 NORTHERN BLVD., SUITE 301 Great Neck, NY 11021 |
| Product Code | FKG |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-29 |
| Decision Date | 1995-05-03 |