CUSTOM PLASTIC PACKS— 510(k) K935622

Substantially Equivalent

Associated Medical

FDA 510(k) clearance K935622 for CUSTOM PLASTIC PACKS, Substantially Equivalent on 1994-02-07. Applicant: Associated Medical.

Clearance details

Applicant: Associated Medical
Product code: Code FRG
Advisory panel: General Hospital
Date received: 1993-11-22
Decision date: 1994-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

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Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

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.