PARAPOST SYSTEM STERILIZABLE ORGANIZER— 510(k) K993835

Substantially Equivalent

Coltene/Whaledent, Inc.

FDA 510(k) clearance K993835 for PARAPOST SYSTEM STERILIZABLE ORGANIZER, Substantially Equivalent on 1999-12-16. Applicant: Coltene/Whaledent, Inc..

Clearance details

Applicant: Coltene/Whaledent, Inc.
Product code: Code FRG
Advisory panel: General Hospital
Date received: 1999-11-12
Decision date: 1999-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, 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.