The following data is part of a premarket notification filed by Packaging Technologies, Inc. with the FDA for Acute Hemodialysis Trays.
| Device ID | K844612 |
| 510k Number | K844612 |
| Device Name: | ACUTE HEMODIALYSIS TRAYS |
| Classification | Accessories, A-v Shunt |
| Applicant | PACKAGING TECHNOLOGIES, INC. 262 GEMINI AVE. Brea, CA 92621 |
| Contact | Robert W Fair |
| Correspondent | Robert W Fair PACKAGING TECHNOLOGIES, INC. 262 GEMINI AVE. Brea, CA 92621 |
| Product Code | KNZ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-27 |
| Decision Date | 1984-12-17 |