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510(k) K880734

SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS by Personal Products Co. — Product Code HHI

K880734 is an FDA 510(k) premarket notification submitted by Personal Products Co. for the device "SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS". The FDA issued a decision of Substantially Equivalent on April 25, 1988. The device falls under product code HHI (System, Abortion, Vacuum), a Class II device regulated under 21 CFR 884.5070. Personal Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1988
Date Received
February 24, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Abortion, Vacuum
Device Class
Class II
Regulation Number
884.5070
Review Panel
OB
Submission Type

Other clearances by Personal Products Co.

  • K070545 — K-Y BRAND WARMING LIQUID (March 23, 2007)
  • K062796 — K-Y BRAND INTRIGUE (December 8, 2006)
  • K010365 — ORTHO CONTROL FEMALE URINARY CONTROL DEVICE (April 30, 2001)
  • K990536 — O.B. TAMPON (August 31, 1999)
  • K991118 — O.B. APPLICATOR TAMPONS, O.B. TAMPONS (June 29, 1999)
  • K974629 — O.B. APPLICATOR AND NON-APPLICATOR TAMPONS (February 10, 1998)
  • K971589 — REACH ANTIBACTERIAL TOOTHBRUSH (July 24, 1997)
  • K970954 — O.B. APPLICATOR TAMPONS (June 10, 1997)
  • K961119 — CAREFREE PANTYLINERS (April 17, 1996)
  • K953638 — O.B. APPLICATOR TAMPONS (October 20, 1995)

Other clearances for product code HHI

  • K171440 — Berkeley VC-10 Vacuum Curettage System (September 29, 2017)
  • K030935 — BERKELEY V-10 VACUUM CURETTAGE SYSTEM (June 23, 2003)
  • K983181 — CYTOPREP (November 16, 1998)
  • K931205 — MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER (March 15, 1994)
  • K904160 — CYTOSMEAR BRUSH (November 2, 1990)
  • K900641 — CANNULA, SUCTION UTERINE (March 30, 1990)
  • K900642 — SWIVEL ADAPTER (March 19, 1990)
  • K873552 — CANNULA AND GENERAL PURPOSE ASPIRATOR (November 25, 1987)
  • K870574 — COSMEDTECH GENERAL ASPIRATOR (March 5, 1987)
  • K870560 — COSMEDTECH CANNULA (March 4, 1987)

FDA data resources