The following data is part of a premarket notification filed by Dyansys, Inc. with the FDA for Drug Relief.
Device ID | K173861 |
510k Number | K173861 |
Device Name: | Drug Relief |
Classification | Percutaneous Nerve Stimulator For Opioid Withdrawal |
Applicant | DyAnsys, Inc. 300 North Bayshore Boulevard San Mateo, CA 94401 |
Contact | San Mateo |
Correspondent | San Mateo DyAnsys, Inc. 300 North Bayshore Boulevard San Mateo, CA 94401 |
Product Code | PZR |
CFR Regulation Number | 882.5896 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-12-20 |
Decision Date | 2018-05-02 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DRUG RELIEF 87672869 5588308 Live/Registered |
Dyansys, Inc. 2017-11-06 |