The following data is part of a premarket notification filed by 3m Health Care with the FDA for 3m 6830 Electrode.
Device ID | K905539 |
510k Number | K905539 |
Device Name: | 3M 6830 ELECTRODE |
Classification | Electrode, Cutaneous |
Applicant | 3M HEALTH CARE MEDICAL SURGICAL DIVISION 3M CENTER St. Paul, MN 55144 |
Contact | Julia L Wannamaker |
Correspondent | Julia L Wannamaker 3M HEALTH CARE MEDICAL SURGICAL DIVISION 3M CENTER St. Paul, MN 55144 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-11 |
Decision Date | 1991-05-28 |