The following data is part of a premarket notification filed by Medical Innovations Corp. with the FDA for Mic Needle Jejunostomy Tube Kit.
Device ID | K880767 |
510k Number | K880767 |
Device Name: | MIC NEEDLE JEJUNOSTOMY TUBE KIT |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | MEDICAL INNOVATIONS CORP. 1595 MC-CANDLESS DR. Milpitas, CA 95035 |
Contact | Rebecca Andersen |
Correspondent | Rebecca Andersen MEDICAL INNOVATIONS CORP. 1595 MC-CANDLESS DR. Milpitas, CA 95035 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-26 |
Decision Date | 1988-08-11 |