The following data is part of a premarket notification filed by Medical Innovations Corp. with the FDA for Mic Gastrostomy Tube Percutaneous Insertion Kit.
| Device ID | K852363 |
| 510k Number | K852363 |
| Device Name: | MIC GASTROSTOMY TUBE PERCUTANEOUS INSERTION KIT |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | MEDICAL INNOVATIONS CORP. 43A SUNOL ST. San Jose, CA 95126 |
| Contact | Stephen K Parks |
| Correspondent | Stephen K Parks MEDICAL INNOVATIONS CORP. 43A SUNOL ST. San Jose, CA 95126 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-04 |
| Decision Date | 1985-08-09 |