The following data is part of a premarket notification filed by Neuromed, Inc. with the FDA for Quadra Cath Elect(3mm Sizes) 1990j, Jf, Jp + Jpf.
| Device ID | K852920 |
| 510k Number | K852920 |
| Device Name: | QUADRA CATH ELECT(3MM SIZES) 1990J, JF, JP + JPF |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | NEUROMED, INC. 5000 A OAKES RD. STE.A. Ft. Lauderdale, FL 33314 |
| Contact | Frank Liska |
| Correspondent | Frank Liska NEUROMED, INC. 5000 A OAKES RD. STE.A. Ft. Lauderdale, FL 33314 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-10 |
| Decision Date | 1985-10-10 |