The following data is part of a premarket notification filed by Leonhard Lang Gmbh with the FDA for Skintact, Various Other Tradenames.
| Device ID | K142803 |
| 510k Number | K142803 |
| Device Name: | Skintact, Various Other Tradenames |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | Leonhard Lang GmbH Archenweg 56 Innsbruck, AU 6020 |
| Contact | Burrhus Lang |
| Correspondent | Elaine Duncan Paladin Medical, Inc. P.O. Box 560 Stillwater, MN 55082 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-29 |
| Decision Date | 2014-12-02 |
| Summary: | summary |