Quadra Cath ELECT(3MM Sizes) 1990J, JF, JP + JPF
FDA 510(k) K852920 · Neuromed, Inc.
510(k) numberK852920
Submission
- Device name
- Quadra Cath ELECT(3MM Sizes) 1990J, JF, JP + JPF
- Applicant
- Neuromed, Inc.
Ft. Lauderdale, FL, US - Received
- July 10, 1985
- Decision date
- October 10, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K960728 | One Step Connect Leads (Quattrode, Octrode, Cervitrode)GZB · Traditional | 05/22/1996SE |
| K930536 | Neuromed Octrode Model MNR-88A-B-C Neurostim RecGZB · Traditional | 12/15/1994SE |
| K930498 | Neuromed Octrode Model MNT-98 Neurostimulator TranGZB · Traditional | 12/12/1994SE |
| K930242 | Introde INT-8GZB · Traditional | 02/02/1994SE |
| K921319 | Neuromed Model OCA-30 Octode and Model SCA-30GZB · Traditional | 05/05/1993SE |
| K905596 | Neuromed Octrode Model MNR-88B/88C Neurostim SystGZB · Traditional | 03/11/1991SE |
| K905255 | Neuromed Model 1992 LS Lamitrode LeadGZB · Traditional | 01/25/1991SE |
| K903814 | Neuromed TS8 Test StimulatorGZB · Traditional | 01/16/1991SE |
| K901499 | Neuromed Octrode Model MNR-88 W/98 Adapter Neuro.GZB · Traditional | 06/29/1990SE |
| K862915 | MULTISTIM(4-CHANNEL), MULTISTIM-OCTRODE(8 Channel)GZB · Traditional | 10/06/1986SE |
Questions and answers
When was Quadra Cath ELECT(3MM Sizes) 1990J, JF, JP + JPF cleared by the FDA?
Quadra Cath ELECT(3MM Sizes) 1990J, JF, JP + JPF (K852920) received a 510(k) decision of Substantially Equivalent on October 10, 1985, 92 days after the submission was received.
What is the product code of K852920?
The FDA product code is GZB – Stimulator, Spinal-Cord, Implanted (Pain Relief), a Class II (moderate risk) device regulated under 21 CFR 882.5880.