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510(k) K864673

UNSCENTED MENSTRUAL PAD by Procter & Gamble Mfg. Co. — Product Code HHL

K864673 is an FDA 510(k) premarket notification submitted by Procter & Gamble Mfg. Co. for the device "UNSCENTED MENSTRUAL PAD". The FDA issued a decision of Substantially Equivalent on January 21, 1987. The device falls under product code HHL (Pad, Menstrual, Scented, Scented-Deodorized), a Class II device regulated under 21 CFR 884.5425. Procter & Gamble Mfg. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1987
Date Received
December 2, 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 by Procter & Gamble Mfg. Co.

  • K873036 — ATTENDS INCONTINENT BRIEF (January 19, 1988)
  • K873457 — SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS (January 19, 1988)
  • K861863 — MODIFIED PROTECTIVE GARMENT (August 11, 1986)
  • K862348 — SINGLE-USE PATIENT UNDERPAD (July 2, 1986)
  • K860598 — MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS (March 5, 1986)
  • K853880 — ATTENDS DISPOS. UNDERPAD (October 16, 1985)
  • K853000 — SCENTED ALWAYS PANTILINERS (September 6, 1985)
  • K852985 — UNSCENTED ALWAYS PANTILINERS (August 29, 1985)
  • K850955 — ALWAYS MAXIPADS - UNSCENTED (May 14, 1985)
  • K850940 — ALWAYS SUPER MAXIPAD-UNSCENTED (May 14, 1985)

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