ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON— 510(k) K965064

Substantially Equivalent

Rostam , Ltd.

FDA 510(k) clearance K965064 for ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON, Substantially Equivalent on 1997-02-20. Applicant: Rostam , Ltd..

Clearance details

Applicant: Rostam , Ltd.
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 1996-12-18
Decision date: 1997-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenfield, IN, US

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Adverse events under product code HEB

product code HEB

Injury: 329
Malfunction: 5,647
Total: 5,976

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.