E-Z-EM(R) LUFKIN BIOPSY NEEDLES— 510(k) K882601
Substantially EquivalentE-Z-Em, Inc.
FDA 510(k) clearance K882601 for E-Z-EM(R) LUFKIN BIOPSY NEEDLES, Substantially Equivalent on 1988-07-25. Applicant: E-Z-Em, Inc.. Device class: 1.
Clearance details
- Applicant
- E-Z-Em, Inc.
- Product code
- Code GDM
- 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
- Westbury, NY, US
Recent devices under product code GDM
view allMore clearances from E-Z-Em, Inc.
view allAdverse events under product code GDM
product code GDM- Death
- 2
- Total
- 2
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.