CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION
FDA 510(k) clearance K852956 · decided 1985-08-09
Clearance details
- K-number
- K852956
- Device name
- CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION
- Applicant
- Parker Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-07-11
- Decision date
- 1985-08-09
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- GYB
- Device class
- 2
- Regulation number
- 882.1275
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Orange, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TENSIVE Conductive Adhesive Gel, REF 016-401600 recall (Z-1305-2024) | Natus Neurology Inc | 2024-03-19 |
| natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amp recall (Z-1306-2024) | Natus Neurology Inc | 2024-03-19 |
| Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes wi recall (Z-1204-2024) | Parker Laboratories, Inc. | 2024-02-29 |