Cleared Traditional

SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS

K873457 · Procter & Gamble Mfg. Co. · Obstetrics & Gynecology

Jan 1988

Decision

144d

Days

Class 2

Risk

About This 510(k) Submission

K873457 is an FDA 510(k) clearance for the SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS, a Tampon, Menstrual, Scented, Scented-deodorized (Class II — Special Controls, product code HIL), submitted by Procter & Gamble Mfg. Co. (Cincinnati, US). The FDA issued a Cleared decision on January 19, 1988, 144 days after receiving the submission on August 28, 1987. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5460.

Submission Details

510(k) Number	K873457 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 28, 1987
Decision Date	January 19, 1988
Days to Decision	144 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.