The following data is part of a premarket notification filed by Macdonald Medical Devices, Inc. with the FDA for Onat Ballooned Nasogastric Tube.
| Device ID | K920262 |
| 510k Number | K920262 |
| Device Name: | ONAT BALLOONED NASOGASTRIC TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | MACDONALD MEDICAL DEVICES, INC. 611 WEST JOHNSON AVE. Cheshire, CT 06410 -1125 |
| Contact | Eric N Randall |
| Correspondent | Eric N Randall MACDONALD MEDICAL DEVICES, INC. 611 WEST JOHNSON AVE. Cheshire, CT 06410 -1125 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-21 |
| Decision Date | 1993-04-20 |