The following data is part of a premarket notification filed by Applied Medical Technology, Inc. with the FDA for Monarch, Transshaping Gastrostomy Tube, Model 9-xx20.
| Device ID | K043027 |
| 510k Number | K043027 |
| Device Name: | MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20 |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | APPLIED MEDICAL TECHNOLOGY, INC. 15653 NEO PKWY. Cleveland, OH 44128 |
| Contact | Derek Williams |
| Correspondent | Derek Williams APPLIED MEDICAL TECHNOLOGY, INC. 15653 NEO PKWY. Cleveland, OH 44128 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-03 |
| Decision Date | 2004-12-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842071116668 | K043027 | 000 |
| 00842071111663 | K043027 | 000 |
| 00842071106942 | K043027 | 000 |
| 00842071106928 | K043027 | 000 |
| 00842071106034 | K043027 | 000 |
| 00842071106027 | K043027 | 000 |
| 00842071106003 | K043027 | 000 |
| 00842071103835 | K043027 | 000 |
| 00842071131654 | K043027 | 000 |
| 00842071131647 | K043027 | 000 |
| 00842071131630 | K043027 | 000 |
| 00842071131623 | K043027 | 000 |
| 00842071131616 | K043027 | 000 |
| 00842071131609 | K043027 | 000 |
| 00842071131593 | K043027 | 000 |
| 00842071131586 | K043027 | 000 |
| 00842071131579 | K043027 | 000 |
| 00842071109288 | K043027 | 000 |
| 00842071111687 | K043027 | 000 |
| 00842071116651 | K043027 | 000 |
| 00842071116583 | K043027 | 000 |
| 00842071116576 | K043027 | 000 |
| 00842071116552 | K043027 | 000 |
| 00842071116545 | K043027 | 000 |
| 00842071116521 | K043027 | 000 |
| 00842071116507 | K043027 | 000 |
| 00842071116385 | K043027 | 000 |
| 00842071116378 | K043027 | 000 |
| 00842071116361 | K043027 | 000 |
| 00842071116354 | K043027 | 000 |
| 00842071116309 | K043027 | 000 |
| 00842071116293 | K043027 | 000 |
| 00842071116286 | K043027 | 000 |
| 00842071116279 | K043027 | 000 |
| 00842071111694 | K043027 | 000 |
| 00842071131562 | K043027 | 000 |