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 |