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510(k) K051413

ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100 by Avent America, Inc. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2005
Date Received
May 31, 2005
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 Avent America, Inc.

  • K052047 — ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101 (September 22, 2005)
  • K952035 — NIPLETTE (July 28, 1995)
  • K944117 — AVENT NIPPLE SHIELD (October 5, 1994)

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