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FDA 510(k)

SAFE'N'SOUND PASSIVE DELIVERY SYSTEM

K-Number: K101233 · 2011-02-18

ApplicantRexam Pharma
Decision Date2011-02-18
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAFE'N'SOUND PASSIVE DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Rexam Pharma. It received FDA 510(k) clearance on 2011-02-18 under 510(k) number K101233. 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'N'SOUND PASSIVE DELIVERY SYSTEM?

SAFE'N'SOUND PASSIVE DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2011-02-18. The listed applicant is Rexam Pharma. The 510(k) number is K101233.

When did SAFE'N'SOUND PASSIVE DELIVERY SYSTEM receive FDA 510(k) clearance?

SAFE'N'SOUND PASSIVE DELIVERY SYSTEM received FDA 510(k) clearance on 2011-02-18, under 510(k) number K101233.

Who is the listed applicant for SAFE'N'SOUND PASSIVE DELIVERY SYSTEM?

The FDA 510(k) record lists Rexam Pharma as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFE'N'SOUND PASSIVE DELIVERY SYSTEM?

The FDA product code for SAFE'N'SOUND PASSIVE DELIVERY SYSTEM is MEG.

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Official Source

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

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