PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET— 510(k) K950178

Name: FDA 510(k) clearance K950178
Creator: U.S. Food and Drug Administration
Published: 1995-07-17

Substantially Equivalent

Pharma-Plast Intl. A/S

FDA 510(k) clearance K950178 for PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET, Substantially Equivalent on 1995-07-17. Applicant: Pharma-Plast Intl. A/S. Device class: 1.

Clearance details

Applicant: Pharma-Plast Intl. A/S
Product code: Code LZE
Device class: Class 1
Regulation: 21 CFR 888.1520
Advisory panel: Orthopedic
Date received: 1995-01-17
Decision date: 1995-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Londonderry, NH, US

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K945617 — PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS INFUSION SETS1995-02-13

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