AVENT NIPPLE SHIELD— 510(k) K944117

Substantially Equivalent

Avent America, Inc.

FDA 510(k) clearance K944117 for AVENT NIPPLE SHIELD, Substantially Equivalent on 1994-10-05. Applicant: Avent America, Inc.. Device class: 1.

Clearance details

Applicant: Avent America, Inc.
Product code: Code HFS
Device class: Class 1
Regulation: 21 CFR 880.5630
Advisory panel: General Hospital
Date received: 1994-08-23
Decision date: 1994-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Addison, IL, US

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Recent devices under product code HFS

K944177 — BREAST SHELL1994-10-05
K935340 — COMFORT PLUS NIPPLE SHIELDS1994-01-21
K935341 — COMFORT PLUS BREAST SHELLS1994-01-21
K930238 — BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS1993-08-16
K923577 — BREAST SHELLS1993-01-22

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