Home / 510(k) Clearances / K834399

510(k) K834399

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

K834399 is an FDA 510(k) premarket notification submitted by Huntleigh Technology, Inc. for the device "NEW MOTHER'S WAY-BREAST PUMP". The FDA issued a decision of Substantially Equivalent on January 17, 1984. The device falls under product code HGY (Pump, Breast, Non-Powered), a Class I device regulated under 21 CFR 884.5150. Huntleigh Technology, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Huntleigh Technology, Inc.

  • K992733 — AKRON ATP9 TRACTION MACHINE (November 10, 1999)
  • K964699 — RHEO DOPPLEX II (RD 2) (February 21, 1997)
  • K924516 — OP3/VP4 (June 28, 1993)
  • K910188 — FLOWPLUS AC330 PUMP GARMENTS (May 28, 1991)
  • 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)

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)
  • K013226 — EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT (December 20, 2001)
  • 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)

FDA data resources