COMFORT PLUS BREAST SHELLS— 510(k) K935341

Name: FDA 510(k) clearance K935341
Creator: U.S. Food and Drug Administration
Published: 1994-01-21

Substantially Equivalent

Marshall Baby Products

FDA 510(k) clearance K935341 for COMFORT PLUS BREAST SHELLS, Substantially Equivalent on 1994-01-21. Applicant: Marshall Baby Products. Device class: 1.

Clearance details

Applicant: Marshall Baby Products
Product code: Code HFS
Device class: Class 1
Regulation: 21 CFR 880.5630
Advisory panel: General Hospital
Date received: 1993-11-05
Decision date: 1994-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HFS

view all

K944117 — AVENT NIPPLE SHIELD1994-10-05
K944177 — BREAST SHELL1994-10-05
K935340 — COMFORT PLUS NIPPLE SHIELDS1994-01-21
K930238 — BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS1993-08-16
K923577 — BREAST SHELLS1993-01-22

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