The following data is part of a premarket notification filed by Allergy & Applicator Depot, Llc with the FDA for Oryum And Ovem Epidermal Deri Prick Test Applicator.
| Device ID | K182582 |
| 510k Number | K182582 |
| Device Name: | Oryum And Ovem Epidermal Deri Prick Test Applicator |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | Allergy & Applicator Depot, LLC 9 Shore Drive Sound Beach, NY 11789 |
| Contact | Steve Tramontano |
| Correspondent | Marc C. Sanchez Contract In-House Counsel And Consultants, LLC (FDA Atty) 53516 Bickett Chapel Hill, NC 27517 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-19 |
| Decision Date | 2019-04-10 |