MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP— 510(k) K890904
Substantially EquivalentShiley, Inc.
FDA 510(k) clearance K890904 for MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP, Substantially Equivalent on 1989-04-12. Applicant: Shiley, Inc.. Device class: 2.
Clearance details
- Applicant
- Shiley, Inc.
- Product code
- Code DWB
- Device class
- Class 2
- Regulation
- 21 CFR 870.4370
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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More clearances from Shiley, Inc.
view allAdverse events under product code DWB
product code DWB- 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.