UNICARE BREAST SHELLS— 510(k) K861608

Name: FDA 510(k) clearance K861608
Creator: U.S. Food and Drug Administration
Published: 1986-07-15

Substantially Equivalent

Unicare Medical Products, Inc.

FDA 510(k) clearance K861608 for UNICARE BREAST SHELLS, Substantially Equivalent on 1986-07-15. Applicant: Unicare Medical Products, Inc.. Device class: 1.

Clearance details

Applicant: Unicare Medical Products, Inc.
Product code: Code HFS
Device class: Class 1
Regulation: 21 CFR 880.5630
Advisory panel: General Hospital
Date received: 1986-04-29
Decision date: 1986-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quebec H4t 1s6, CA

Download summary PDF View on FDA.gov ↗

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K930238 — BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS1993-08-16

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