The following data is part of a premarket notification filed by Trident Surgical Corp. with the FDA for Disposable Electrode.
Device ID | K820664 |
510k Number | K820664 |
Device Name: | DISPOSABLE ELECTRODE |
Classification | Apparatus, Electrosurgical |
Applicant | TRIDENT SURGICAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HAM |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-03-11 |
Decision Date | 1982-03-19 |