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510(k) K971231

WHITE RIVER MINI MANUAL BREAST PUMP by White River Concepts — Product Code HGY

K971231 is an FDA 510(k) premarket notification submitted by White River Concepts for the device "WHITE RIVER MINI MANUAL BREAST PUMP". The FDA issued a decision of Substantially Equivalent on May 19, 1997. The device falls under product code HGY (Pump, Breast, Non-Powered), a Class I device regulated under 21 CFR 884.5150. White River Concepts has 2 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1997
Date Received
Apr 3, 1997
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
510(k) Exempt

Other clearances by White River Concepts

  • K970488 — HYDROCHECK MICRO FILTER (Nov 4, 1997)
  • K964679 — WHITE RIVER AUTOMATIC BREAST PUMP (Jun 10, 1997)

Other clearances for product code HGY

  • K101538 — HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) (Nov 5, 2010)
  • K032845 — EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187 (Apr 5, 2004)
  • K013226 — EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT (Dec 20, 2001)
  • K011519 — AMEDA HYGIENIKIT (Aug 15, 2001)
  • K962828 — EVERT-IT (Feb 10, 1997)
  • K952034 — MEDELA'S FOOT PUMP (Sep 12, 1995)
  • K952035 — NIPLETTE (Jul 28, 1995)
  • K925738 — WHITE RIVER MANUAL BREAST PUMP (May 4, 1994)
  • K912355 — MOTHERS TOUCH ONE HAND BREAST PUMP (Dec 10, 1993)
  • K902552 — GERBER PRECIOUS CARE ELECTRIC BREAST PUMP (Sep 26, 1990)

FDA data resources

Source: FDA 510(k) database entry for K971231. Report a data issue: hello@regdatalab.com.