The following data is part of a premarket notification filed by Newmark, Inc. with the FDA for Painmaster Mct Patch.
| Device ID | K090042 |
| 510k Number | K090042 |
| Device Name: | PAINMASTER MCT PATCH |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | NEWMARK, INC. 919 EIGHTEENTH STREET NW SUITE 600 Washington, DC 20006 |
| Contact | Deborah Livornese |
| Correspondent | Deborah Livornese NEWMARK, INC. 919 EIGHTEENTH STREET NW SUITE 600 Washington, DC 20006 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-06 |
| Decision Date | 2009-05-06 |
| Summary: | summary |