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510(k) K870066

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

K870066 is an FDA 510(k) premarket notification submitted by Cascades Psh, Inc. for the device "KAY-PLUS & VARIOUS VANIA SANITARY LINERS & PADS". The FDA issued a decision of Substantially Equivalent on June 19, 1987. The device falls under product code HHL (Pad, Menstrual, Scented, Scented-Deodorized), a Class II device regulated under 21 CFR 884.5425.

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

  • K962962 — DEODORANT PANTY LINER (October 10, 1996)
  • K962953 — DEODORANT PANTY SHIELD (October 10, 1996)
  • K962954 — DEODORANT MAXI PAD (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)

FDA data resources