The following data is part of a premarket notification filed by Applied Medical Technology, Inc. with the FDA for Amt G-j Tube.
Device ID | K110804 |
510k Number | K110804 |
Device Name: | AMT G-J TUBE |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | APPLIED MEDICAL TECHNOLOGY, INC. 8000 KATHERINE BOULEVARD Brecksville, OH 44141 |
Contact | Joshua D Meinke |
Correspondent | Joshua D Meinke APPLIED MEDICAL TECHNOLOGY, INC. 8000 KATHERINE BOULEVARD Brecksville, OH 44141 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-03-22 |
Decision Date | 2011-10-19 |