The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Rusch Miller-abbott Tube.
| Device ID | K010797 |
| 510k Number | K010797 |
| Device Name: | RUSCH MILLER-ABBOTT TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | RUSCH INTL. 50 PLANTATION DR. Jaffery, NH 03452 |
| Contact | Julie A Beaumont |
| Correspondent | Julie A Beaumont RUSCH INTL. 50 PLANTATION DR. Jaffery, NH 03452 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-16 |
| Decision Date | 2002-02-26 |