The following data is part of a premarket notification filed by Nouvag Ag with the FDA for Morce Power Plus And Variocarve Morcellator.
| Device ID | K080365 |
| 510k Number | K080365 |
| Device Name: | MORCE POWER PLUS AND VARIOCARVE MORCELLATOR |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | NOUVAG AG REUSSWEHRSTRASSE 1 Gebenstorf, CH Ch-5412 |
| Contact | Erich Forster |
| Correspondent | Erich Forster NOUVAG AG REUSSWEHRSTRASSE 1 Gebenstorf, CH Ch-5412 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-11 |
| Decision Date | 2009-06-29 |
| Summary: | summary |