The following data is part of a premarket notification filed by Sodemsystems with the FDA for Sodem Perforator Drive.
Device ID | K993851 |
510k Number | K993851 |
Device Name: | SODEM PERFORATOR DRIVE |
Classification | Motor, Drill, Pneumatic |
Applicant | SODEMSYSTEMS 110, CH. DU PONT-DU-CENTENAIRE Geneva, Switzerland, CH Ch 1228 |
Contact | Daniel Baccino |
Correspondent | Daniel Baccino SODEMSYSTEMS 110, CH. DU PONT-DU-CENTENAIRE Geneva, Switzerland, 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 | 1999-11-12 |
Decision Date | 1999-12-27 |
Summary: | summary |