The following data is part of a premarket notification filed by Applied Medical Technology, Inc. with the FDA for Amt T-fastener Anchor Kit.
| Device ID | K120587 |
| 510k Number | K120587 |
| Device Name: | AMT T-FASTENER ANCHOR KIT |
| Classification | Tube, Gastro-enterostomy |
| Applicant | APPLIED MEDICAL TECHNOLOGY, INC. 8000 KATHERINE BOULEVARD Brecksville, OH 44141 |
| Contact | Elizabeth Meyer |
| Correspondent | Elizabeth Meyer APPLIED MEDICAL TECHNOLOGY, INC. 8000 KATHERINE BOULEVARD Brecksville, OH 44141 |
| Product Code | KGC |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-27 |
| Decision Date | 2012-05-25 |