MODIFIED INTENDED USE OF MONOJECT BONE MARROW NEED— 510(k) K883014
Substantially EquivalentSherwood Medical Co.
FDA 510(k) clearance K883014 for MODIFIED INTENDED USE OF MONOJECT BONE MARROW NEED, Substantially Equivalent on 1988-07-28. 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
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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.