The following data is part of a premarket notification filed by Medical Innovations Corp. with the FDA for Mic Jejunal Feeding Tube.
Device ID | K853197 |
510k Number | K853197 |
Device Name: | MIC JEJUNAL FEEDING TUBE |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | MEDICAL INNOVATIONS CORP. 43A SUNOL ST. San Jose, CA 95126 |
Contact | Stephen K Parks |
Correspondent | Stephen K Parks MEDICAL INNOVATIONS CORP. 43A SUNOL ST. San Jose, CA 95126 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-07-30 |
Decision Date | 1985-08-22 |