The following data is part of a premarket notification filed by Applied Medical Technology, Inc. with the FDA for Amt Suture Delivery System.
| Device ID | K193612 |
| 510k Number | K193612 |
| Device Name: | AMT Suture Delivery System |
| Classification | Tube, Gastro-enterostomy |
| Applicant | Applied Medical Technology, Inc. 8006 Katherine Blvd. Brecksville, OH 44141 |
| Contact | Joy Tubero |
| Correspondent | Joy Tubero Applied Medical Technology, Inc. 8006 Katherine Blvd. Brecksville, OH 44141 |
| Product Code | KGC |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-26 |
| Decision Date | 2020-03-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842071131203 | K193612 | 000 |
| 00842071131180 | K193612 | 000 |