The following data is part of a premarket notification filed by Nouvag Ag with the FDA for Micro-motorsystems Md20, Sem2, Highsurg 20 & Dt55.
| Device ID | K042434 |
| 510k Number | K042434 |
| Device Name: | MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55 |
| Classification | Drill, Bone, Powered |
| Applicant | NOUVAG AG REUSSWEHRSTRASSE 1 Gebenstorf, CH 5412 |
| Contact | Erich Forster |
| Correspondent | Erich Forster NOUVAG AG REUSSWEHRSTRASSE 1 Gebenstorf, CH 5412 |
| Product Code | DZI |
| Subsequent Product Code | ERL |
| Subsequent Product Code | HBC |
| Subsequent Product Code | HBE |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-08 |
| Decision Date | 2004-11-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| ENOU1706A0 | K042434 | 000 |
| ENOU2004CAM0 | K042434 | 000 |
| ENOU2004IDI0 | K042434 | 000 |
| ENOU2004SAL0 | K042434 | 000 |
| ENOU20050 | K042434 | 000 |
| ENOU2005CAM0 | K042434 | 000 |
| ENOU2005IDI0 | K042434 | 000 |
| ENOU20070 | K042434 | 000 |
| ENOU2007SAL0 | K042434 | 000 |
| ENOU20160 | K042434 | 000 |
| ENOU2016IDI0 | K042434 | 000 |
| ENOU2016IMP0 | K042434 | 000 |
| ENOU20260 | K042434 | 000 |
| ENOU2026IDI0 | K042434 | 000 |
| ENOU20040 | K042434 | 000 |
| ENOU1962NOU0 | K042434 | 000 |
| ENOU1706B0 | K042434 | 000 |
| ENOU1710NOU0 | K042434 | 000 |
| ENOU1903NOU0 | K042434 | 000 |
| ENOU1904NOU0 | K042434 | 000 |
| ENOU1905NOU0 | K042434 | 000 |
| ENOU1906NOU0 | K042434 | 000 |
| ENOU1907NOU0 | K042434 | 000 |
| ENOU1908NOU0 | K042434 | 000 |
| ENOU1950NOU0 | K042434 | 000 |
| ENOU1951NOU0 | K042434 | 000 |
| ENOU1952NOU0 | K042434 | 000 |
| ENOU1960NOU0 | K042434 | 000 |
| ENOU1961NOU0 | K042434 | 000 |
| ENOU20270 | K042434 | 000 |
| ENOU2027ABD0 | K042434 | 000 |
| ENOU33350 | K042434 | 000 |
| ENOU3335ABD0 | K042434 | 000 |
| ENOU3335IDI0 | K042434 | 000 |
| ENOU3335OXY0 | K042434 | 000 |
| ENOU3335SAL0 | K042434 | 000 |
| ENOU33600 | K042434 | 000 |
| ENOU33610 | K042434 | 000 |
| ENOU33650 | K042434 | 000 |
| ENOU33900 | K042434 | 000 |
| ENOU33910 | K042434 | 000 |
| ENOU3391FOC0 | K042434 | 000 |
| ENOU17069 | K042434 | 000 |
| ENOU1706ZIM9 | K042434 | 000 |
| ENOU3330SAL0 | K042434 | 000 |
| ENOU3330IMP0 | K042434 | 000 |
| ENOU2027IDI0 | K042434 | 000 |
| ENOU2027M0 | K042434 | 000 |
| ENOU2027OXY0 | K042434 | 000 |
| ENOU2027SAL0 | K042434 | 000 |
| ENOU20280 | K042434 | 000 |
| ENOU2028ABD0 | K042434 | 000 |
| ENOU2028IDI0 | K042434 | 000 |
| ENOU2028OXY0 | K042434 | 000 |
| ENOU2097NOU0 | K042434 | 000 |
| ENOU2116NOU0 | K042434 | 000 |
| ENOU33300 | K042434 | 000 |
| ENOU3330CAM0 | K042434 | 000 |
| ENOU3330IDI0 | K042434 | 000 |
| ENOU17089 | K042434 | 000 |