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FDA 510(k)

EMODREN EXCHANGEABLE PLASTIC BELLOWS

K-Number: K853295 · 1985-08-20

ApplicantParexel Intl. Corp.
Decision Date1985-08-20
Product CodeGCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EMODREN EXCHANGEABLE PLASTIC BELLOWS is the device name listed in this FDA 510(k) record. The listed applicant is Parexel Intl. Corp.. It received FDA 510(k) clearance on 1985-08-20 under 510(k) number K853295. The device is classified under product code GCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMODREN EXCHANGEABLE PLASTIC BELLOWS?

EMODREN EXCHANGEABLE PLASTIC BELLOWS is a medical device that received FDA 510(k) clearance on 1985-08-20. The listed applicant is Parexel Intl. Corp.. The 510(k) number is K853295.

When did EMODREN EXCHANGEABLE PLASTIC BELLOWS receive FDA 510(k) clearance?

EMODREN EXCHANGEABLE PLASTIC BELLOWS received FDA 510(k) clearance on 1985-08-20, under 510(k) number K853295.

Who is the listed applicant for EMODREN EXCHANGEABLE PLASTIC BELLOWS?

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

What is the FDA product code for EMODREN EXCHANGEABLE PLASTIC BELLOWS?

The FDA product code for EMODREN EXCHANGEABLE PLASTIC BELLOWS is GCY.

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Related Devices (Code: GCY)

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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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