The following data is part of a premarket notification filed by Medical Innovations Corp. with the FDA for Mic Gastrostomy Tube.
| Device ID | K842076 |
| 510k Number | K842076 |
| Device Name: | MIC GASTROSTOMY TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | MEDICAL INNOVATIONS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Contact | _ _ |
| Correspondent | _ _ MEDICAL INNOVATIONS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-23 |
| Decision Date | 1984-08-14 |