The following data is part of a premarket notification filed by Cher Mel Corp. with the FDA for Disposable Intravenous Hyperalimentation Bags.
| Device ID | K863040 |
| 510k Number | K863040 |
| Device Name: | DISPOSABLE INTRAVENOUS HYPERALIMENTATION BAGS |
| Classification | Container, I.v. |
| Applicant | CHER MEL CORP. P.O. BOX 68624 Seattle, WA 98168 |
| Contact | Cheryl Amundsen |
| Correspondent | Cheryl Amundsen CHER MEL CORP. P.O. BOX 68624 Seattle, WA 98168 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-12 |
| Decision Date | 1986-10-31 |