The following data is part of a premarket notification filed by Imed Technology, Inc. with the FDA for Med Gravity Set, Imed Pump Set.
Device ID | K102712 |
510k Number | K102712 |
Device Name: | MED GRAVITY SET, IMED PUMP SET |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | IMED TECHNOLOGY, INC. 17408 TAMARON DRIVE Dallas, TX 75287 |
Contact | Brandon Converse |
Correspondent | Brandon Converse IMED TECHNOLOGY, INC. 17408 TAMARON DRIVE Dallas, TX 75287 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-20 |
Decision Date | 2011-12-16 |