The following data is part of a premarket notification filed by Medical Innovations Corp. with the FDA for Mic Gastro-enterostomy Tube Modification.
| Device ID | K921370 |
| 510k Number | K921370 |
| Device Name: | MIC GASTRO-ENTEROSTOMY TUBE MODIFICATION |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | MEDICAL INNOVATIONS CORP. 1595 MC-CANDLESS DR. Milpitas, CA 95035 |
| Contact | Dennis Wong |
| Correspondent | Dennis Wong MEDICAL INNOVATIONS CORP. 1595 MC-CANDLESS DR. Milpitas, CA 95035 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-20 |
| Decision Date | 1994-05-02 |