RELIANCE MOD-U-LINE M-700— 510(k) K761147

Substantially Equivalent

F. & F. Koenigkramer

FDA 510(k) clearance K761147 for RELIANCE MOD-U-LINE M-700, Substantially Equivalent on 1977-01-28. Applicant: F. & F. Koenigkramer.

Clearance details

Applicant: F. & F. Koenigkramer
Product code: Code FPO
Advisory panel: General Hospital
Date received: 1976-11-26
Decision date: 1977-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FPO

product code FPO

Death: 29
Injury: 254
Malfunction: 5,054
Other: 10
Total: 5,347

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.