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510(k) K013226

EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT by Evenflo Company, Inc. — Product Code HGY

K013226 is an FDA 510(k) premarket notification submitted by Evenflo Company, Inc. for the device "EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT". The FDA issued a decision of Substantially Equivalent on December 20, 2001. The device falls under product code HGY (Pump, Breast, Non-Powered), a Class I device regulated under 21 CFR 884.5150. Evenflo Company, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2001
Date Received
September 27, 2001
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 Evenflo Company, Inc.

  • K102600 — SIMPLYGO BREAST PUMP (December 22, 2010)
  • K100435 — AMEDA PLATINUM BREAST PUMP (May 28, 2010)
  • K092770 — SIMPLYGO HANDS FREE BREAST PUMP (October 9, 2009)
  • K082307 — EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT (September 11, 2008)
  • K053493 — BERRY FRUITY TEETHER (February 22, 2006)
  • K052909 — EVENFLO ELAN BREAST PUMP (November 1, 2005)
  • K022933 — EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT (December 2, 2002)

Other clearances for product code HGY

  • K101538 — HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) (November 5, 2010)
  • K032845 — EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187 (April 5, 2004)
  • 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