AXICARE BREAST SHELL— 510(k) K811364

Substantially Equivalent

Neonatal Corp.

FDA 510(k) clearance K811364 for AXICARE BREAST SHELL, Substantially Equivalent on 1981-08-03. Applicant: Neonatal Corp.. Device class: 1.

Clearance details

Applicant: Neonatal Corp.
Product code: Code HFS
Device class: Class 1
Regulation: 21 CFR 880.5630
Advisory panel: General Hospital
Date received: 1981-05-14
Decision date: 1981-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HFS

K944117 — AVENT NIPPLE SHIELD1994-10-05
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

More clearances from Neonatal Corp.

K811707 — AXICUT DISPOSABLE SCALPEL1981-07-20
K811403 — AXICARE BREAST PUMP MODEL1981-06-12

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