The following data is part of a premarket notification filed by Aa Neuromed Corp. with the FDA for Neuromed Electroanalgesic Delivery Systems.
Device ID | K083250 |
510k Number | K083250 |
Device Name: | NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | AA NEUROMED CORP. 1911 RODGER AVENUE Port Coquitlam, Bc, CA V3c 1b8 |
Contact | Hermann Dolker |
Correspondent | Hermann Dolker AA NEUROMED CORP. 1911 RODGER AVENUE Port Coquitlam, Bc, CA V3c 1b8 |
Product Code | GZJ |
Subsequent Product Code | IPF |
Subsequent Product Code | LIH |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-11-04 |
Decision Date | 2009-08-18 |
Summary: | summary |