Cleared Traditional

O.B. APPLICATOR TAMPONS, O.B. TAMPONS

K991118 · Personal Products Co. · Obstetrics & Gynecology

Jun 1999

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K991118 is an FDA 510(k) clearance for the O.B. APPLICATOR TAMPONS, O.B. TAMPONS, a Tampon, Menstrual, Unscented (Class II — Special Controls, product code HEB), submitted by Personal Products Co. (Skillman, US). The FDA issued a Cleared decision on June 29, 1999, 89 days after receiving the submission on April 1, 1999. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K991118 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 01, 1999
Decision Date	June 29, 1999
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

Device Classification

Product Code	HEB — Tampon, Menstrual, Unscented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.5470
Definition	An Unscented Menstrual Tampon Is A Plug Made Of Cellulosic Or Synthetic Material That Is Inserted Into The Vagina And Used To Absorb Menstrual Fluid Or Other Vaginal Discharge.