MONOJECT BONE MARROW BIOPSY TRAYS— 510(k) K945109
Substantially EquivalentSherwood Medical Co.
FDA 510(k) clearance K945109 for MONOJECT BONE MARROW BIOPSY TRAYS, Substantially Equivalent on 1994-11-14. Applicant: Sherwood Medical Co.. Device class: 1.
Clearance details
- Applicant
- Sherwood Medical Co.
- Product code
- Code GAA
- Device class
- Class 1
- Regulation
- 21 CFR 878.4800
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
Recent devices under product code GAA
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- K960677 — KANGAROO JEJUNAL FEEDING SYSTEM
Adverse events under product code GAA
product code GAA- Malfunction
- 834
- Total
- 834
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.