MONOJECTOR MONOLET LANCER— 510(k) K820333
Substantially EquivalentSherwood Medical Co.
FDA 510(k) clearance K820333 for MONOJECTOR MONOLET LANCER, Substantially Equivalent on 1982-03-10. Applicant: Sherwood Medical Co.. Device class: 2.
Clearance details
- Applicant
- Sherwood Medical Co.
- Product code
- Code FMK
- Device class
- Class 2
- Regulation
- 21 CFR 878.4850
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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- K960677 — KANGAROO JEJUNAL FEEDING SYSTEM
Adverse events under product code FMK
product code FMK- Injury
- 133
- Malfunction
- 1,278
- Other
- 1
- Total
- 1,412
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.