The following data is part of a premarket notification filed by Medical Innovations Corp. with the FDA for Mic Peg Tube.
Device ID | K924065 |
510k Number | K924065 |
Device Name: | MIC PEG TUBE |
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 With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-27 |
Decision Date | 1994-02-17 |