The following data is part of a premarket notification filed by Leonhard Lang Gmbh with the FDA for Skintact Cool Contact Electrosurgical Grounding Plate With Nh 04 Gel.
| Device ID | K063161 |
| 510k Number | K063161 |
| Device Name: | SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | LEONHARD LANG GMBH P.O. BOX 560 Stillwater, MN 55082 -0560 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan LEONHARD LANG GMBH P.O. BOX 560 Stillwater, MN 55082 -0560 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-17 |
| Decision Date | 2006-11-21 |
| Summary: | summary |