The following data is part of a premarket notification filed by Applied Medical Technologies with the FDA for A.m.t. G-tube Balloon Replacement Gastrostomy Feeding Device.
| Device ID | K971434 |
| 510k Number | K971434 |
| Device Name: | A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | APPLIED MEDICAL TECHNOLOGIES 15653 NEO PKWY. Cleveland, OH 44128 -3150 |
| Contact | Thomas W Parkinson |
| Correspondent | Thomas W Parkinson APPLIED MEDICAL TECHNOLOGIES 15653 NEO PKWY. Cleveland, OH 44128 -3150 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-18 |
| Decision Date | 1998-08-17 |