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510(k) K953633

UNSCENTED MENSTRUAL PAD by Tendasoft, Inc. — Product Code HHD

K953633 is an FDA 510(k) premarket notification submitted by Tendasoft, Inc. for the device "UNSCENTED MENSTRUAL PAD". The FDA issued a decision of Substantially Equivalent on November 1, 1995. 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
November 1, 1995
Date Received
August 4, 1995
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)
  • 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)

FDA data resources