The following data is part of a premarket notification filed by Dale Medical Products, Inc. with the FDA for Nasogastric Tube Holder, Model 160.
| Device ID | K994300 |
| 510k Number | K994300 |
| Device Name: | NASOGASTRIC TUBE HOLDER, MODEL 160 |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | DALE MEDICAL PRODUCTS, INC. 7 CROSS ST. P.O. BOX 1556 Plainville, MA 02762 |
| Contact | John C Brezack |
| Correspondent | John C Brezack DALE MEDICAL PRODUCTS, INC. 7 CROSS ST. P.O. BOX 1556 Plainville, MA 02762 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-21 |
| Decision Date | 2000-02-10 |