The following data is part of a premarket notification filed by Acme United Corp. with the FDA for One Time Enteral Feeding Bag.
| Device ID | K860818 |
| 510k Number | K860818 |
| Device Name: | ONE TIME ENTERAL FEEDING BAG |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ACME UNITED CORP. 425 POST RD. Fairfield, CT 06430 |
| Contact | Susan L Carey |
| Correspondent | Susan L Carey ACME UNITED CORP. 425 POST RD. Fairfield, CT 06430 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-04 |
| Decision Date | 1986-05-15 |