AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP— 510(k) K980976
Substantially EquivalentHollister, Inc.
FDA 510(k) clearance K980976 for AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP, Substantially Equivalent on 1998-08-21. Applicant: Hollister, Inc.. Device class: 2.
Clearance details
- Applicant
- Hollister, 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
- Libertyville, IL, 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.