The following data is part of a premarket notification filed by Chartermed, Inc. with the FDA for 600 Or 1200 Ml. Enteral Bag Administration Set.
| Device ID | K901753 |
| 510k Number | K901753 |
| Device Name: | 600 OR 1200 ML. ENTERAL BAG ADMINISTRATION SET |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | CHARTERMED, INC. 70 OBERLIN AVENUE NORTH Lakewood, NJ 08701 |
| Contact | Peter G Hussey |
| Correspondent | Peter G Hussey CHARTERMED, INC. 70 OBERLIN AVENUE NORTH Lakewood, NJ 08701 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-16 |
| Decision Date | 1990-06-01 |