Cleared Traditional

O.B. SLENDER REGULAR TAMPON

K870539 · Personal Products Co. · Obstetrics & Gynecology

Mar 1987

Decision

37d

Days

Class 2

Risk

About This 510(k) Submission

K870539 is an FDA 510(k) clearance for the O.B. SLENDER REGULAR TAMPON, a Tampon, Menstrual, Unscented (Class II — Special Controls, product code HEB), submitted by Personal Products Co. (Milltown, US). The FDA issued a Cleared decision on March 18, 1987, 37 days after receiving the submission on February 9, 1987. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K870539 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 09, 1987
Decision Date	March 18, 1987
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	—

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.