The following data is part of a premarket notification filed by Micromedics, Inc. with the FDA for Shikani Middle Meatal Antrostomy Vent Tube.
| Device ID | K912418 |
| 510k Number | K912418 |
| Device Name: | SHIKANI MIDDLE MEATAL ANTROSTOMY VENT TUBE |
| Classification | Cannula, Sinus |
| Applicant | MICROMEDICS, INC. 268 E. LAFAYETTE FRONTAGE ROAD St. Paul, MN 55107 |
| Contact | Curtis H Miller |
| Correspondent | Curtis H Miller MICROMEDICS, INC. 268 E. LAFAYETTE FRONTAGE ROAD St. Paul, MN 55107 |
| Product Code | KAM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-31 |
| Decision Date | 1991-12-20 |