The following data is part of a premarket notification filed by Gimmi Gmbh with the FDA for Alphahysteroscope, Fiberoptic, Operative And Diagnostic.
| Device ID | K092421 |
| 510k Number | K092421 |
| Device Name: | ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC |
| Classification | Hysteroscope (and Accessories) |
| Applicant | GIMMI GMBH ONE SCANLAN PLAZA Saint Paul, MN 55107 |
| Contact | Ken Blake |
| Correspondent | Ken Blake GIMMI GMBH ONE SCANLAN PLAZA Saint Paul, MN 55107 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-07 |
| Decision Date | 2010-02-12 |
| Summary: | summary |