The following data is part of a premarket notification filed by Cutter Laboratories, Inc. with the FDA for Total Parenteral Nutrition Set Bag.
| Device ID | K801652 |
| 510k Number | K801652 |
| Device Name: | TOTAL PARENTERAL NUTRITION SET BAG |
| Classification | Container, I.v. |
| Applicant | CUTTER LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-18 |
| Decision Date | 1980-08-27 |