FEMORAL CANAL SUCTION TAMPON— 510(k) K831999
Substantially EquivalentRichards Manufacturer Co.
FDA 510(k) clearance K831999 for FEMORAL CANAL SUCTION TAMPON, Substantially Equivalent on 1983-09-29. Applicant: Richards Manufacturer Co.. Device class: 2.
Clearance details
- Applicant
- Richards Manufacturer Co.
- Product code
- Code JOL
- Device class
- Class 2
- Regulation
- 21 CFR 880.6740
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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More clearances from Richards Manufacturer Co.
view allAdverse events under product code JOL
product code JOL- Death
- 7
- Injury
- 177
- Malfunction
- 1,306
- Other
- 1
- Total
- 1,491
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.