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510(k) K964679

WHITE RIVER AUTOMATIC BREAST PUMP by White River Concepts — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1997
Date Received
November 21, 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 White River Concepts

  • K970488 — HYDROCHECK MICRO FILTER (November 4, 1997)
  • K971231 — WHITE RIVER MINI MANUAL BREAST PUMP (May 19, 1997)

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