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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842071118532 | K971434 | 000 |
| 00842071116217 | K971434 | 000 |
| 00842071114817 | K971434 | 000 |
| 00842071114800 | K971434 | 000 |
| 00842071114794 | K971434 | 000 |
| 00842071114787 | K971434 | 000 |
| 00842071114770 | K971434 | 000 |
| 00842071106218 | K971434 | 000 |
| 00842071106195 | K971434 | 000 |
| 00842071106171 | K971434 | 000 |
| 00842071106157 | K971434 | 000 |
| 00842071103668 | K971434 | 000 |
| 00842071103637 | K971434 | 000 |
| 00842071131241 | K971434 | 000 |
| 00842071131234 | K971434 | 000 |
| 00842071116224 | K971434 | 000 |
| 00842071116231 | K971434 | 000 |
| 00842071118525 | K971434 | 000 |
| 00842071118518 | K971434 | 000 |
| 00842071118501 | K971434 | 000 |
| 00842071118495 | K971434 | 000 |
| 00842071118488 | K971434 | 000 |
| 00842071116446 | K971434 | 000 |
| 00842071116439 | K971434 | 000 |
| 00842071116422 | K971434 | 000 |
| 00842071116415 | K971434 | 000 |
| 00842071116408 | K971434 | 000 |
| 00842071116392 | K971434 | 000 |
| 00842071116262 | K971434 | 000 |
| 00842071116255 | K971434 | 000 |
| 00842071116248 | K971434 | 000 |
| 00842071131227 | K971434 | 000 |