The following data is part of a premarket notification filed by Laerdal Medical As with the FDA for Reusable Full Silicone Cover.
| Device ID | K151702 |
| 510k Number | K151702 |
| Device Name: | Reusable Full Silicone Cover |
| Classification | Aid, Cardiopulmonary Resuscitation |
| Applicant | LAERDAL MEDICAL AS TANKE SVILANDSGATE 30 Stavanger, NO 4007 |
| Contact | Mari Kaada |
| Correspondent | Dan Dillon MED INSTITUTE 1330 WIN HENTSCHEL BOULEVARD, STE 100 West Lafayette, IN 47906 |
| Product Code | LIX |
| CFR Regulation Number | 870.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-24 |
| Decision Date | 2015-08-13 |
| Summary: | summary |