The following data is part of a premarket notification filed by Sodem Systems with the FDA for Drill Guide Attachment (pn 3105 Dg) Of The Sodem High Speed System (pneumatic).
| Device ID | K023066 |
| 510k Number | K023066 |
| Device Name: | DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC) |
| Classification | Motor, Drill, Pneumatic |
| Applicant | SODEM SYSTEMS 110 CH. DU PONT DU CENTENAIRE Geneva, CH Ch-1228 |
| Contact | Carole Burnier |
| Correspondent | Carole Burnier SODEM SYSTEMS 110 CH. DU PONT DU CENTENAIRE Geneva, CH Ch-1228 |
| Product Code | HBB |
| CFR Regulation Number | 882.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-16 |
| Decision Date | 2002-11-25 |
| Summary: | summary |