EGNELL ELITE— 510(k) K950531
Substantially EquivalentHollister, Inc.
FDA 510(k) clearance K950531 for EGNELL ELITE, Substantially Equivalent on 1995-09-22. Applicant: Hollister, Inc.. Device class: 2.
Clearance details
- Applicant
- Hollister, Inc.
- Product code
- Product code HGX
- Device class
- Class 2
- Regulation
- 21 CFR 884.5160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cary, IL, US
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Adverse events under product code HGX
product code HGX- Injury
- 758
- Other
- 2
- Total
- 760
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.