The following data is part of a premarket notification filed by Axelgaard Mfg. Co., Ltd. with the FDA for Valuetrode.
Device ID | K970426 |
510k Number | K970426 |
Device Name: | VALUETRODE |
Classification | Electrode, Cutaneous |
Applicant | AXELGAARD MFG. CO., LTD. 329 W. AVIATION RD. Fallbrook, CA 92028 -3227 |
Contact | Dan Jeffery |
Correspondent | Dan Jeffery AXELGAARD MFG. CO., LTD. 329 W. AVIATION RD. Fallbrook, CA 92028 -3227 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-02-04 |
Decision Date | 1997-05-09 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00861039000399 | K970426 | 000 |
00888912340816 | K970426 | 000 |
00888912340830 | K970426 | 000 |
00888912340847 | K970426 | 000 |
00888912340854 | K970426 | 000 |
00888912340861 | K970426 | 000 |
00888912340991 | K970426 | 000 |
00888912341004 | K970426 | 000 |
00888912341011 | K970426 | 000 |
00888912341028 | K970426 | 000 |
00888912341202 | K970426 | 000 |
15099058719004 | K970426 | 000 |
00861039000375 | K970426 | 000 |
00861039000382 | K970426 | 000 |
00888912023580 | K970426 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VALUETRODE 75265577 not registered Dead/Abandoned |
AXELGAARD MANUFACTURING COMPANY, LTD. 1997-03-28 |