The following data is part of a premarket notification filed by Marc Pro with the FDA for Mpp.
Device ID | K131910 |
510k Number | K131910 |
Device Name: | MPP |
Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
Applicant | MARC PRO 3722 AVE. SAUSALITO Irvine, CA 92606 |
Contact | Greg Holland |
Correspondent | Greg Holland MARC PRO 3722 AVE. SAUSALITO Irvine, CA 92606 |
Product Code | NUH |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-06-26 |
Decision Date | 2014-01-24 |
Summary: | summary |