The following data is part of a premarket notification filed by Ferris Mfg. Corp. with the FDA for Tensagain.
Device ID | K872574 |
510k Number | K872574 |
Device Name: | TENSAGAIN |
Classification | Electrode, Cutaneous |
Applicant | FERRIS MFG. CORP. 16W300 83RD ST. Burr Ridge, IL 60527 -5848 |
Contact | Lalagos |
Correspondent | Lalagos FERRIS MFG. CORP. 16W300 83RD ST. Burr Ridge, IL 60527 -5848 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-30 |
Decision Date | 1987-07-23 |