The following data is part of a premarket notification filed by The Dezac Group with the FDA for Conductive Gel.
Device ID | K022006 |
510k Number | K022006 |
Device Name: | CONDUCTIVE GEL |
Classification | Media, Electroconductive |
Applicant | THE DEZAC GROUP 719 A ST. NE Washington, DC 20002 |
Contact | Wendy Parsley |
Correspondent | Wendy Parsley THE DEZAC GROUP 719 A ST. NE Washington, DC 20002 |
Product Code | GYB |
CFR Regulation Number | 882.1275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-06-19 |
Decision Date | 2002-09-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860196000327 | K022006 | 000 |
00860196000310 | K022006 | 000 |
00850021097561 | K022006 | 000 |