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510(k) K834399

NEW MOTHER'S WAY-BREAST PUMP by Huntleigh Technology, Inc. — Product Code HGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1984
Date Received
December 14, 1983
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

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  • K900882 — MULTI DOPPLEX, MD-1 (August 22, 1990)
  • K900618 — HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140 (April 25, 1990)
  • K890012 — HUNTLEIGH DYNAMIC FLOTATION SYSTEM (March 29, 1989)
  • K884451 — DOPCORD PPG (January 12, 1989)
  • K881632 — FLOWTRON DVT SYSTEM AC500 PUMP, L501 GARMENT (September 26, 1988)
  • K874688 — FLOWTRON AC200/2 (September 23, 1988)

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  • 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)