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510(k) K012629

ALWAYS DUETS by Procter & Gamble Co. — Product Code HHD

K012629 is an FDA 510(k) premarket notification submitted by Procter & Gamble Co. for the device "ALWAYS DUETS". The FDA issued a decision of Substantially Equivalent on October 5, 2001. The device falls under product code HHD (Pad, Menstrual, Unscented), a Class I device regulated under 21 CFR 884.5435. Procter & Gamble Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2001
Date Received
August 13, 2001
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 Procter & Gamble Co.

  • K203567 — Oral-B Dry Mouth Oral Rinse (April 5, 2021)
  • K201277 — Oral-B Dry Mouth Oral Rinse (September 2, 2020)
  • K200881 — Oral-B iO Test Drive Power Brush Trial Program Kit (August 27, 2020)
  • K151413 — Always/Tampax bladder supports (December 18, 2015)
  • K141018 — ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBR (September 15, 2014)
  • K133244 — TAMPAX M PLASTIC TAMPONS, UNSCENTED (January 9, 2014)
  • K131543 — TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED (June 20, 2013)
  • K113699 — TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED (January 12, 2012)
  • K110669 — TAMPAX C PLASTIC TAMPONS, UNSCENTED (June 2, 2011)
  • K091281 — TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL (June 1, 2010)

Other clearances for product code HHD

  • K071827 — ALWAYS MENSTRUAL PADS (September 20, 2007)
  • 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)
  • K953633 — UNSCENTED MENSTRUAL PAD (November 1, 1995)
  • K953553 — UNSCENTED MENSTRAL PAD (October 27, 1995)
  • K953517 — UNSCENTED MENSTRUAL PAD (October 26, 1995)

FDA data resources