The following data is part of a premarket notification filed by Sanexas Intl. Gmbh with the FDA for Neogenesys 2k.
Device ID | K022433 |
510k Number | K022433 |
Device Name: | NEOGENESYS 2K |
Classification | Interferential Current Therapy |
Applicant | SANEXAS INTL. GMBH 200 NE MULBERRY Lee's Summit, MO 64086 |
Contact | Gene Kelly |
Correspondent | Gene Kelly SANEXAS INTL. GMBH 200 NE MULBERRY Lee's Summit, MO 64086 |
Product Code | LIH |
Subsequent Product Code | GZJ |
Subsequent Product Code | IPF |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-07-25 |
Decision Date | 2003-01-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860000214018 | K022433 | 000 |
00860000214001 | K022433 | 000 |
00860000214049 | K022433 | 000 |
00860000214032 | K022433 | 000 |