SARNS 9000 UNIVERSAL ROLLER PUMP— 510(k) K953904
Substantially Equivalent3M Health Care, Ltd.
FDA 510(k) clearance K953904 for SARNS 9000 UNIVERSAL ROLLER PUMP, Substantially Equivalent on 1996-04-19. Applicant: 3M Health Care, Ltd.. Device class: 2.
Clearance details
- Applicant
- 3M Health Care, Ltd.
- 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
- Ann Arbor, MI, US
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- K972321 — S3 MAST PUMP
More clearances from 3M Health Care, Ltd.
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.