The following data is part of a premarket notification filed by Leonhard Lang Gmbh with the FDA for Skintact.
| Device ID | K140340 |
| 510k Number | K140340 |
| Device Name: | SKINTACT |
| Classification | Electrode, Cutaneous |
| 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 | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-11 |
| Decision Date | 2014-05-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24053815072946 | K140340 | 000 |
| 24053815072939 | K140340 | 000 |
| 24053815072922 | K140340 | 000 |
| 24053815072915 | K140340 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SKINTACT 75055394 not registered Dead/Abandoned |
Benchmark Commercial, Inc. 1996-02-07 |
![]() SKINTACT 74591097 2362444 Live/Registered |
Leonhard Lang 1994-10-27 |