The following data is part of a premarket notification filed by National Medical Care, Medical Products Div., Inc. with the FDA for Naturalyte Mixer.
| Device ID | K883408 |
| 510k Number | K883408 |
| Device Name: | NATURALYTE MIXER |
| Classification | Tank, Holding, Dialysis |
| Applicant | NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. TWO VOLVO DR. Rockleigh, NJ 07647 |
| Contact | Del Donna |
| Correspondent | Del Donna NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. TWO VOLVO DR. Rockleigh, NJ 07647 |
| Product Code | FIN |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-11 |
| Decision Date | 1988-10-31 |