The following data is part of a premarket notification filed by Leonhard Lang Gmbh with the FDA for Skintact Cool Contact Electrosurgical Grounding Plates.
| Device ID | K030362 |
| 510k Number | K030362 |
| Device Name: | SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATES |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-03 |
| Decision Date | 2003-04-14 |
| Summary: | summary |