COMAN(R) CU-11 MODEL NUMBER 82-6634— 510(k) K945585
Substantially EquivalentJohnson & Johnson Professionals, Inc.
FDA 510(k) clearance K945585 for COMAN(R) CU-11 MODEL NUMBER 82-6634, Substantially Equivalent on 1995-10-26. Applicant: Johnson & Johnson Professionals, Inc..
Clearance details
- Applicant
- Johnson & Johnson Professionals, Inc.
- Product code
- Code GWM
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raritan, NJ, US
Adverse events under product code GWM
product code GWM- Death
- 21
- Injury
- 732
- Malfunction
- 2,063
- Other
- 1
- Total
- 2,817
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.