The following data is part of a premarket notification filed by Venusa Ltd. with the FDA for Enteral Feeding Bag, 1000 Ml, & Tubing Set.
| Device ID | K851975 |
| 510k Number | K851975 |
| Device Name: | ENTERAL FEEDING BAG, 1000 ML, & TUBING SET |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | VENUSA LTD. 95 NEWFIELD AVE. RARITAN CENTER Edison, NJ 08837 |
| Contact | Ronald J Guida |
| Correspondent | Ronald J Guida VENUSA LTD. 95 NEWFIELD AVE. RARITAN CENTER Edison, NJ 08837 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-07 |
| Decision Date | 1985-09-05 |