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FDA 510(k)

SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM

K-Number: K112936 · 2012-01-20

ApplicantRexam Consummer Plastics Inc.D/B/A Rexam Pharma
Decision Date2012-01-20
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Rexam Consummer Plastics Inc.D/B/A Rexam Pharma. It received FDA 510(k) clearance on 2012-01-20 under 510(k) number K112936. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM?

SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2012-01-20. The listed applicant is Rexam Consummer Plastics Inc.D/B/A Rexam Pharma. The 510(k) number is K112936.

When did SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM receive FDA 510(k) clearance?

SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM received FDA 510(k) clearance on 2012-01-20, under 510(k) number K112936.

Who is the listed applicant for SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM?

The FDA 510(k) record lists Rexam Consummer Plastics Inc.D/B/A Rexam Pharma as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM?

The FDA product code for SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM is MEG.

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Official Source

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