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 |