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510(k) K942814

SELF SUPER MAXI SNAITARY NAPKINS by Kegan & Kegan, Ltd. — Product Code HHD

K942814 is an FDA 510(k) premarket notification submitted by Kegan & Kegan, Ltd. for the device "SELF SUPER MAXI SNAITARY NAPKINS". The FDA issued a decision of Substantially Equivalent on August 5, 1994. The device falls under product code HHD (Pad, Menstrual, Unscented), a Class I device regulated under 21 CFR 884.5435.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1994
Date Received
June 15, 1994
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.

Other clearances for product code HHD

  • K071827 — ALWAYS MENSTRUAL PADS (September 20, 2007)
  • K012629 — ALWAYS DUETS (October 5, 2001)
  • K003843 — ENVIVE MINIFORMS (February 8, 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)

FDA data resources