BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS— 510(k) K930238

Name: FDA 510(k) clearance K930238
Creator: U.S. Food and Drug Administration
Published: 1993-08-16

Substantially Equivalent

Prolac, Inc.

FDA 510(k) clearance K930238 for BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS, Substantially Equivalent on 1993-08-16. Applicant: Prolac, Inc.. Device class: 1.

Clearance details

Applicant: Prolac, Inc.
Product code: Code HFS
Device class: Class 1
Regulation: 21 CFR 880.5630
Advisory panel: General Hospital
Date received: 1993-01-19
Decision date: 1993-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skaneateles, NY, US

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K935341 — COMFORT PLUS BREAST SHELLS1994-01-21
K923577 — BREAST SHELLS1993-01-22

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