AB VACUUM EXTRACTOR SILC-CUP— 510(k) K841492
Substantially EquivalentMedela, Inc.
FDA 510(k) clearance K841492 for AB VACUUM EXTRACTOR SILC-CUP, Substantially Equivalent on 1984-05-07. Applicant: Medela, Inc.. Device class: 2.
Clearance details
- Applicant
- Medela, Inc.
- Product code
- Code HDB
- Device class
- Class 2
- Regulation
- 21 CFR 884.4340
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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Adverse events under product code HDB
product code HDB- Death
- 7
- Total
- 7
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.