The following data is part of a premarket notification filed by Applied Medical Technology, Inc. with the FDA for Amt Initial Placement Gi Kit (e2418) And Amt Dilator Set (e2419).
| Device ID | K073034 |
| 510k Number | K073034 |
| Device Name: | AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419) |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | APPLIED MEDICAL TECHNOLOGY, INC. 15653 NEO PKWY. Cleveland, OH 44128 |
| Contact | Brian Baker |
| Correspondent | Brian Baker APPLIED MEDICAL TECHNOLOGY, INC. 15653 NEO PKWY. Cleveland, OH 44128 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-26 |
| Decision Date | 2008-03-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842071106867 | K073034 | 000 |
| 00842071106850 | K073034 | 000 |
| 00842071106843 | K073034 | 000 |
| 00842071130602 | K073034 | 000 |
| 00842071130596 | K073034 | 000 |
| 00842071131432 | K073034 | 000 |
| 00842071131425 | K073034 | 000 |
| 00842071131876 | K073034 | 000 |