Cleared Traditional

O.B.(TM) TAMPON

K864498 · Personal Products Co. · Obstetrics & Gynecology

Jan 1987

Decision

74d

Days

Class 2

Risk

About This 510(k) Submission

K864498 is an FDA 510(k) clearance for the O.B.(TM) TAMPON, a Tampon, Menstrual, Scented, Scented-deodorized (Class II — Special Controls, product code HIL), submitted by Personal Products Co. (Milltown, US). The FDA issued a Cleared decision on January 27, 1987, 74 days after receiving the submission on November 14, 1986. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5460.

Submission Details

510(k) Number	K864498 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 14, 1986
Decision Date	January 27, 1987
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	—

Device Classification

Product Code	HIL — Tampon, Menstrual, Scented, Scented-deodorized
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.5460
Definition	A Scented Or Scented-deodorized 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.