The following data is part of a premarket notification filed by American Medical Technologies, Inc. with the FDA for Amt Nanocath.
| Device ID | K050557 |
| 510k Number | K050557 |
| Device Name: | AMT NANOCATH |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | AMERICAN MEDICAL TECHNOLOGIES, INC. 1211 WEST 13TH ST. Riviera Beach, FL 33404 |
| Contact | Michael Renick |
| Correspondent | Michael Renick AMERICAN MEDICAL TECHNOLOGIES, INC. 1211 WEST 13TH ST. Riviera Beach, FL 33404 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-03 |
| Decision Date | 2005-05-27 |
| Summary: | summary |