The following data is part of a premarket notification filed by Ethox Corp. with the FDA for Ethox/barron Food Pump Gavage Bag Sets.
| Device ID | K801144 |
| 510k Number | K801144 |
| Device Name: | ETHOX/BARRON FOOD PUMP GAVAGE BAG SETS |
| Classification | Set, Gavage, Infant, Sterile |
| Applicant | ETHOX CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FHT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-13 |
| Decision Date | 1980-06-09 |