The following data is part of a premarket notification filed by Encision Inc. with the FDA for Endoshield Burn Protection System.
| Device ID | K140006 |
| 510k Number | K140006 |
| Device Name: | ENDOSHIELD BURN PROTECTION SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ENCISION INC. 6707 WINCHESTER CIRCLE Boulder, CO 80303 |
| Contact | Mike Biggs |
| Correspondent | Mike Biggs ENCISION INC. 6707 WINCHESTER CIRCLE Boulder, CO 80303 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-02 |
| Decision Date | 2014-06-16 |
| Summary: | summary |