PDI PREPMASTER WET PACK PATIENT PREP KIT— 510(k) K840342

Substantially Equivalent

Nice-Pak Products, Inc.

FDA 510(k) clearance K840342 for PDI PREPMASTER WET PACK PATIENT PREP KIT, Substantially Equivalent on 1984-03-27. Applicant: Nice-Pak Products, Inc..

Clearance details

Applicant: Nice-Pak Products, Inc.
Product code: Code FRG
Advisory panel: General Hospital
Date received: 1984-01-06
Decision date: 1984-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.