The following data is part of a premarket notification filed by Medical Innovations Corp. with the FDA for Mic Mushroom Tip Gastrostomy Tube.
Device ID | K872531 |
510k Number | K872531 |
Device Name: | MIC MUSHROOM TIP GASTROSTOMY TUBE |
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 | 1987-06-26 |
Decision Date | 1987-09-04 |