The following data is part of a premarket notification filed by E Surgical, Llc with the FDA for Electrosurgical Infant Patient Return Electrode, Dual Plate With Cord, Model Ep 211m.
| Device ID | K071080 |
| 510k Number | K071080 |
| Device Name: | ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL EP 211M |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | E SURGICAL, LLC 1910 N. CALIFORNIA BLVD. SUITE 1040 Walnut Creek, CA 94596 |
| Contact | Hans J Richter |
| Correspondent | Hans J Richter E SURGICAL, LLC 1910 N. CALIFORNIA BLVD. SUITE 1040 Walnut Creek, CA 94596 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-17 |
| Decision Date | 2007-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30614559104235 | K071080 | 000 |
| 30614559104228 | K071080 | 000 |
| 30614559102774 | K071080 | 000 |
| 30614559100909 | K071080 | 000 |