TUTTNAUER PREVACUUM TABLE AUTOCLAVE— 510(k) K962282

Substantially Equivalent

Tuttnauer U.S.A Co, Ltd.

FDA 510(k) clearance K962282 for TUTTNAUER PREVACUUM TABLE AUTOCLAVE, Substantially Equivalent on 1997-11-12. Applicant: Tuttnauer U.S.A Co, Ltd..

Clearance details

Applicant: Tuttnauer U.S.A Co, Ltd.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 1996-06-12
Decision date: 1997-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ronkonkoma, NY, US

Download summary PDF View on FDA.gov ↗

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.