The following data is part of a premarket notification filed by Micromedics, Inc. with the FDA for Rhino-guard.
| Device ID | K911785 |
| 510k Number | K911785 |
| Device Name: | RHINO-GUARD |
| Classification | Nebulizer (direct Patient Interface) |
| 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 | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-22 |
| Decision Date | 1991-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00385640000277 | K911785 | 000 |
| 00385640000260 | K911785 | 000 |
| 00385640000086 | K911785 | 000 |
| 00385640000079 | K911785 | 000 |