O.B. APPLICATOR TAMPONS— 510(k) K970954

Name: FDA 510(k) clearance K970954
Creator: U.S. Food and Drug Administration
Published: 1997-06-10

Substantially Equivalent

Personal Products Co.

FDA 510(k) clearance K970954 for O.B. APPLICATOR TAMPONS, Substantially Equivalent on 1997-06-10. Applicant: Personal Products Co.. Device class: 2.

Clearance details

Applicant: Personal Products Co.
Product code: Code HEB
Device class: Class 2
Regulation: 21 CFR 884.5470
Advisory panel: Obstetrics/Gynecology
Date received: 1997-03-17
Decision date: 1997-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skillman, NJ, US

Download summary PDF View on FDA.gov ↗

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K010365 — ORTHO CONTROL FEMALE URINARY CONTROL DEVICE2001-04-30
K990536 — O.B. TAMPON1999-08-31
K991118 — O.B. APPLICATOR TAMPONS, O.B. TAMPONS1999-06-29

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.