510(k) K961119

CAREFREE PANTYLINERS by Personal Products Co. — Product Code HHL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 17, 1996
Date Received: March 21, 1996
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 by Personal Products Co.

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K062796 — K-Y BRAND INTRIGUE (December 8, 2006)
K010365 — ORTHO CONTROL FEMALE URINARY CONTROL DEVICE (April 30, 2001)
K990536 — O.B. TAMPON (August 31, 1999)
K991118 — O.B. APPLICATOR TAMPONS, O.B. TAMPONS (June 29, 1999)
K974629 — O.B. APPLICATOR AND NON-APPLICATOR TAMPONS (February 10, 1998)
K971589 — REACH ANTIBACTERIAL TOOTHBRUSH (July 24, 1997)
K970954 — O.B. APPLICATOR TAMPONS (June 10, 1997)
K953638 — O.B. APPLICATOR TAMPONS (October 20, 1995)
K941863 — O.B. TAMPON (June 27, 1994)

Other clearances for product code HHL

K962953 — DEODORANT PANTY SHIELD (October 10, 1996)
K962962 — DEODORANT PANTY LINER (October 10, 1996)
K962954 — DEODORANT MAXI PAD (October 10, 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)
K884444 — MAXITHINS REGULAR PADS, DEODORANT (December 5, 1988)