Device |
tube, single lumen, with mercury wt balloon for intestinal intubation and / or decompression |
Regulation Description |
Gastrointestinal tube and accessories. |
Regulation Medical Specialty |
Gastroenterology/Urology |
Review Panel |
Gastroenterology/Urology |
Product Code | FEF |
Premarket Review |
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
|
Submission Type |
510(k)
|
Regulation Number |
876.5980
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standards
|
Guidance Document
|
Third Party Review
|
Accredited Persons
|