LOOP/SQUARE ELECTRODE— 510(k) K952030
Substantially EquivalentE & M Engineering, Inc.
FDA 510(k) clearance K952030 for LOOP/SQUARE ELECTRODE, Substantially Equivalent on 1996-07-31. Applicant: E & M Engineering, Inc.. Device class: 2.
Clearance details
- Applicant
- E & M Engineering, Inc.
- Product code
- Code HGI
- Device class
- Class 2
- Regulation
- 21 CFR 884.4120
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Richmond, VA, US
Recent devices under product code HGI
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view allAdverse events under product code HGI
product code HGI- Other
- 1
- Total
- 1
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 →
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