The following data is part of a premarket notification filed by Medovations, Inc. with the FDA for Maloney Bouge (1210-xx)/hurst Bougie (1212-xx).
| Device ID | K972119 |
| 510k Number | K972119 |
| Device Name: | MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) |
| Classification | Bougie, Esophageal, And Gastrointestinal, Gastro-urology |
| Applicant | MEDOVATIONS, INC. W194 N11340 MCCORMICK DR. Germantown, WI 53022 |
| Contact | Charles G Stanford |
| Correspondent | Charles G Stanford MEDOVATIONS, INC. W194 N11340 MCCORMICK DR. Germantown, WI 53022 |
| Product Code | FAT |
| CFR Regulation Number | 876.5365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-05 |
| Decision Date | 1998-02-02 |