The following data is part of a premarket notification filed by Marchan Medical, Llc with the FDA for Pat (pain Alleviation Technologies).
Device ID | K182267 |
510k Number | K182267 |
Device Name: | PAT (Pain Alleviation Technologies) |
Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
Applicant | Marchan Medical, LLC 165 S Ashe St. Southern Pines, NC 28387 |
Contact | Mark Chandler |
Correspondent | Mark Chandler Marchan Medical, LLC 165 S Ashe St. Southern Pines, NC 28387 |
Product Code | NUH |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-08-21 |
Decision Date | 2019-02-27 |
Summary: | summary |