The following data is part of a premarket notification filed by Medical Innovations Corp. with the FDA for Mic (specific Line) Replacement Kit.
| Device ID | K880768 |
| 510k Number | K880768 |
| Device Name: | MIC (SPECIFIC LINE) REPLACEMENT 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 | 1988-04-22 |