The following data is part of a premarket notification filed by Obtech Medical Sarl with the FDA for Realize Gastric Calibration Tube, Models Gct180, Gct360.
| Device ID | K071764 |
| 510k Number | K071764 |
| Device Name: | REALIZE GASTRIC CALIBRATION TUBE, MODELS GCT180, GCT360 |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | OBTECH MEDICAL SARL 4545 CREEK RD. Cincinnati, OH 45242 |
| Contact | Elizabeth Miller |
| Correspondent | Elizabeth Miller OBTECH MEDICAL SARL 4545 CREEK RD. Cincinnati, OH 45242 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-29 |
| Decision Date | 2007-10-24 |
| Summary: | summary |