MOTHERS TOUCH ONE HAND BREAST PUMP— 510(k) K912355

Name: FDA 510(k) clearance K912355
Creator: U.S. Food and Drug Administration
Published: 1993-12-10

Substantially Equivalent

Hollister, Inc.

FDA 510(k) clearance K912355 for MOTHERS TOUCH ONE HAND BREAST PUMP, Substantially Equivalent on 1993-12-10. Applicant: Hollister, Inc.. Device class: 1.

Clearance details

Applicant: Hollister, Inc.
Product code: Code HGY
Device class: Class 1
Regulation: 21 CFR 884.5150
Advisory panel: Obstetrics/Gynecology
Date received: 1991-05-28
Decision date: 1993-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HGY

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K101538 — HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)2010-11-05
K032845 — EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 11872004-04-05
K013226 — EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT2001-12-20
K011519 — AMEDA HYGIENIKIT2001-08-15
K971231 — WHITE RIVER MINI MANUAL BREAST PUMP1997-05-19

More clearances from Hollister, Inc.

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Recalls naming K912355

K-number listed on FDA's recall record

Z-1326-2015 — Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75") within a secondary corrugated shipper (16 x 11.02 x 5.12" inner dimensions). The device is indicated for assisted expression of milk using manual suction.Class II·Terminated·Ameda, Inc.·20150212

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K912355.

Data sourced from openFDA. This site is unofficial and independent of the FDA.