The following data is part of a premarket notification filed by Applied Medical Technology, Inc. with the FDA for Traditional Length Gj Feeding Device.
Device ID | K182804 |
510k Number | K182804 |
Device Name: | Traditional Length GJ Feeding Device |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | Applied Medical Technology, Inc. 8006 Katherine Boulevard Brecksville, OH 44141 |
Contact | Joy Tubero |
Correspondent | Joy Tubero Applied Medical Technology, Inc. 8006 Katherine Boulevard Brecksville, OH 44141 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-10-02 |
Decision Date | 2019-03-01 |
Summary: | summary |