The following data is part of a premarket notification filed by Applied Medical Technology Inc. with the FDA for Low Profile Non-balloon Feeding Device.
Device ID | K170319 |
510k Number | K170319 |
Device Name: | Low Profile Non-Balloon Feeding Device |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | APPLIED MEDICAL TECHNOLOGY INC. 8006 KATHERINE BOULEVARD Brecksville, OH 44141 |
Contact | Shraddha Saini |
Correspondent | Shraddha Saini 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 | 2017-02-01 |
Decision Date | 2017-10-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00842071132156 | K170319 | 000 |
00842071132057 | K170319 | 000 |
00842071132064 | K170319 | 000 |
00842071132071 | K170319 | 000 |
00842071132088 | K170319 | 000 |
00842071132095 | K170319 | 000 |
00842071132101 | K170319 | 000 |
00842071132118 | K170319 | 000 |
00842071132125 | K170319 | 000 |
00842071132132 | K170319 | 000 |
00842071132149 | K170319 | 000 |
00842071132040 | K170319 | 000 |