DIAL MEDICAL KIT— 510(k) K941543
UnknownRegulatory & Marketing Services, Inc.
FDA 510(k) clearance K941543 for DIAL MEDICAL KIT, Unknown on 1995-02-16. Applicant: Regulatory & Marketing Services, Inc.. Device class: 2.
Clearance details
- Applicant
- Regulatory & Marketing Services, Inc.
- Product code
- Code KOC
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Palm Harbor, FL, US
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More clearances from Regulatory & Marketing Services, Inc.
view allAdverse events under product code KOC
product code KOC- Death
- 4
- Total
- 4
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.