The following data is part of a premarket notification filed by Debusk Technology Corp. with the FDA for Electrosurgical Dispersive Electrode And Electrosurgical Dual Return Electrode With Conductive Gel And 10 Ft. Cord.
Device ID | K940299 |
510k Number | K940299 |
Device Name: | ELECTROSURGICAL DISPERSIVE ELECTRODE AND ELECTROSURGICAL DUAL RETURN ELECTRODE WITH CONDUCTIVE GEL AND 10 FT. CORD |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | DEBUSK TECHNOLOGY CORP. 200 DEBUSK LN. Powell, TN 37849 |
Contact | Debra F Manning |
Correspondent | Debra F Manning DEBUSK TECHNOLOGY CORP. 200 DEBUSK LN. Powell, TN 37849 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-21 |
Decision Date | 1994-05-02 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50749756601448 | K940299 | 000 |
50749756279999 | K940299 | 000 |