510(k) K003843

ENVIVE MINIFORMS by Procter & Gamble Co. — Product Code HHD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 8, 2001
Date Received: December 12, 2000
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Pad, Menstrual, Unscented
Device Class: Class I
Regulation Number: 884.5435
Review Panel: OB
Submission Type

An unscented menstrual pad which is used to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic and synthetic material with an established safety profile.

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Other clearances for product code HHD

K071827 — ALWAYS MENSTRUAL PADS (September 20, 2007)
K012629 — ALWAYS DUETS (October 5, 2001)
K993870 — UNSCENTED INTERLABIAL MENSTRUAL PAD (January 18, 2000)
K980395 — GLADRAGS COTTON MENSTRUAL PAD (April 16, 1998)
K953470 — FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS) (November 21, 1995)
K953633 — UNSCENTED MENSTRUAL PAD (November 1, 1995)
K953668 — UNSCENTED ULTRATHIN MAXI PAD (November 1, 1995)
K953667 — UNSCENTED CURVED ULTRATHIN MAXI PADS (November 1, 1995)
K953553 — UNSCENTED MENSTRAL PAD (October 27, 1995)
K953517 — UNSCENTED MENSTRUAL PAD (October 26, 1995)