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510(k) K820960

MAXI & MINI SHIELDS by Dafoe & Dafoe, Inc. — Product Code HHD

K820960 is an FDA 510(k) premarket notification submitted by Dafoe & Dafoe, Inc. for the device "MAXI & MINI SHIELDS". The FDA issued a decision of Substantially Equivalent on May 14, 1982. The device falls under product code HHD (Pad, Menstrual, Unscented), a Class I device regulated under 21 CFR 884.5435. Dafoe & Dafoe, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1982
Date Received
April 6, 1982
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 by Dafoe & Dafoe, Inc.

  • K820962 — COTTON SWABS (April 20, 1982)
  • K820961 — INCONTINENCE PAD OR ADULT DIAPER (April 16, 1982)
  • K800747 — BELTLESS MAXI, MINI & SUPER MAXI PADS (April 29, 1980)

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)
  • K953633 — UNSCENTED MENSTRUAL PAD (November 1, 1995)
  • K953667 — UNSCENTED CURVED ULTRATHIN MAXI PADS (November 1, 1995)
  • K953553 — UNSCENTED MENSTRAL PAD (October 27, 1995)

FDA data resources