510(k) K870066

KAY-PLUS & VARIOUS VANIA SANITARY LINERS & PADS by Cascades Psh, Inc. — Product Code HHL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 19, 1987
Date Received: December 22, 1986
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Pad, Menstrual, Scented, Scented-Deodorized
Device Class: Class II
Regulation Number: 884.5425
Review Panel: OB
Submission Type

Scented or scented-deodorized menstrual pads used to absorb menstrual or other vaginal discharge, including those intended as intralabial pads or reusable menstrual pads. These are made with materials that do not meet the requirements for Class 1 per 21 CFR 884.5425(b).

Other clearances for product code HHL

K962953 — DEODORANT PANTY SHIELD (October 10, 1996)
K962954 — DEODORANT MAXI PAD (October 10, 1996)
K962962 — DEODORANT PANTY LINER (October 10, 1996)
K961119 — CAREFREE PANTYLINERS (April 17, 1996)
K913237 — ALWAYS, SCENTED/SCENTED DEODORIZED MENSTRUAL PAD (September 23, 1991)
K913238 — ALWAYS, UNSCENTED MENSTRUAL PAD (September 23, 1991)
K891473 — TAMPAX ULTRAFIT PANTY SHIELDS/DEDORANT-MODIFICATIO (June 7, 1989)
K890655 — NEW FREEDOM THIN DEODORANT MAXI PADS (May 1, 1989)
K884951 — TAMPAX ULTRAFIT PANTY SHIELDS, DEODORANT (January 10, 1989)
K884446 — MAXITHINS SUPER PADS, DEODORANT (December 20, 1988)