STEAM STERILIZER (AUTOCLAVE), DENTAL— 510(k) K895638

Substantially Equivalent

Porter Instrument Co., Inc.

FDA 510(k) clearance K895638 for STEAM STERILIZER (AUTOCLAVE), DENTAL, Substantially Equivalent on 1990-02-22. Applicant: Porter Instrument Co., Inc..

Clearance details

Applicant: Porter Instrument Co., Inc.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 1989-09-19
Decision date: 1990-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hatfield, PA, US

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Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

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.