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510(k) K032845

EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187 by The First Years, Inc. — Product Code HGY

K032845 is an FDA 510(k) premarket notification submitted by The First Years, Inc. for the device "EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187". The FDA issued a decision of Substantially Equivalent on April 5, 2004. The device falls under product code HGY (Pump, Breast, Non-Powered), a Class I device regulated under 21 CFR 884.5150. The First Years, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2004
Date Received
September 11, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Non-Powered
Device Class
Class I
Regulation Number
884.5150
Review Panel
OB
Submission Type

Other clearances by The First Years, Inc.

  • K033131 — NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068 (October 30, 2003)
  • K032566 — NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP (September 15, 2003)
  • K964403 — SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068) (January 13, 1997)

Other clearances for product code HGY

  • K101538 — HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) (November 5, 2010)
  • K013226 — EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT (December 20, 2001)
  • K011519 — AMEDA HYGIENIKIT (August 15, 2001)
  • K971231 — WHITE RIVER MINI MANUAL BREAST PUMP (May 19, 1997)
  • K962828 — EVERT-IT (February 10, 1997)
  • K952034 — MEDELA'S FOOT PUMP (September 12, 1995)
  • K952035 — NIPLETTE (July 28, 1995)
  • K925738 — WHITE RIVER MANUAL BREAST PUMP (May 4, 1994)
  • K912355 — MOTHERS TOUCH ONE HAND BREAST PUMP (December 10, 1993)
  • K902552 — GERBER PRECIOUS CARE ELECTRIC BREAST PUMP (September 26, 1990)

FDA data resources