PORTABLE ASPIRATOR— 510(k) K791210

Substantially Equivalent

Sam Say Assoc.

FDA 510(k) clearance K791210 for PORTABLE ASPIRATOR, Substantially Equivalent on 1979-07-24. Applicant: Sam Say Assoc..

Clearance details

Applicant: Sam Say Assoc.
Product code: Code JCX
Advisory panel: General, Plastic Surgery
Date received: 1979-07-02
Decision date: 1979-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.