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510(k) K840325

INFA COMPLETE BREAST PUMP & MILK STORAG by Monterey Laboratories, Inc. — Product Code HGY

K840325 is an FDA 510(k) premarket notification submitted by Monterey Laboratories, Inc. for the device "INFA COMPLETE BREAST PUMP & MILK STORAG". The FDA issued a decision of Substantially Equivalent on March 5, 1984. The device falls under product code HGY (Pump, Breast, Non-Powered), a Class I device regulated under 21 CFR 884.5150.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1984
Date Received
January 25, 1984
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 for product code HGY

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  • 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