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510(k) K964403

SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068) by The First Years, Inc. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1997
Date Received
November 4, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Powered
Device Class
Class II
Regulation Number
884.5160
Review Panel
OB
Submission Type

Other clearances by The First Years, Inc.

  • K032845 — EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187 (April 5, 2004)
  • K033131 — NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068 (October 30, 2003)
  • K032566 — NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP (September 15, 2003)

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