The following data is part of a premarket notification filed by Applied Medical Technology, Inc. with the FDA for Amt Introducer: Mini Button Delivery System.
| Device ID | K042300 |
| 510k Number | K042300 |
| Device Name: | AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | APPLIED MEDICAL TECHNOLOGY, INC. 15653 NEO PKWY. Cleveland, OH 44128 |
| Contact | Chris Zantopulos |
| Correspondent | Chris Zantopulos APPLIED MEDICAL TECHNOLOGY, INC. 15653 NEO PKWY. Cleveland, OH 44128 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-24 |
| Decision Date | 2004-10-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842071111809 | K042300 | 000 |
| 00842071111793 | K042300 | 000 |
| 00842071130626 | K042300 | 000 |
| 00842071131173 | K042300 | 000 |
| 00842071133191 | K042300 | 000 |