60 ML RESERVOIR BAG, ITEM #200— 510(k) K875155

Name: FDA 510(k) clearance K875155
Creator: U.S. Food and Drug Administration
Published: 1988-02-16

Substantially Equivalent

Prn Services, Inc.

FDA 510(k) clearance K875155 for 60 ML RESERVOIR BAG, ITEM #200, Substantially Equivalent on 1988-02-16. Applicant: Prn Services, Inc.. Device class: 2.

Clearance details

Applicant: Prn Services, Inc.
Product code: Code KPE
Device class: Class 2
Regulation: 21 CFR 880.5025
Advisory panel: General Hospital
Date received: 1987-12-15
Decision date: 1988-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Royal Oak, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KPE

product code KPE

Malfunction: 1,000
Other: 1
Total: 1,001

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.