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FDA 510(k)

PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET

K-Number: K950178 · 1995-07-17

ApplicantPharma-Plast Intl. A/S
Decision Date1995-07-17
Product CodeLZE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Pharma-Plast Intl. A/S. It received FDA 510(k) clearance on 1995-07-17 under 510(k) number K950178. The device is classified under product code LZE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET?

PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET is a medical device that received FDA 510(k) clearance on 1995-07-17. The listed applicant is Pharma-Plast Intl. A/S. The 510(k) number is K950178.

When did PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET receive FDA 510(k) clearance?

PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET received FDA 510(k) clearance on 1995-07-17, under 510(k) number K950178.

Who is the listed applicant for PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET?

The FDA 510(k) record lists Pharma-Plast Intl. A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET?

The FDA product code for PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET is LZE.

Related Clinical Trials

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Other records listing Pharma-Plast Intl. A/S as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K945617PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS INFUSION SETS

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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