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 |