The following data is part of a premarket notification filed by E Surgical, Llc with the FDA for E Surgical Electrosurgical Patient Return Electrode, Dual Plate With Cord And Electrosurgical Patient Return Electrode.
Device ID | K060255 |
510k Number | K060255 |
Device Name: | E SURGICAL ELECTROSURGICAL PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD AND ELECTROSURGICAL PATIENT RETURN ELECTRODE |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | E SURGICAL, LLC 4655 KIRKWOOD COURT Boulder, CO 80301 |
Contact | Lewis Ward |
Correspondent | Lewis Ward E SURGICAL, LLC 4655 KIRKWOOD COURT Boulder, CO 80301 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-02-01 |
Decision Date | 2006-03-31 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10888867062594 | K060255 | 000 |
30614559100879 | K060255 | 000 |