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FDA 510(k)

PCI CUSTOM DESIGN SERIES

K-Number: K861943 · 1986-05-30

ApplicantPoston & Cole Intl.
Decision Date1986-05-30
Product CodeIQC
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PCI CUSTOM DESIGN SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Poston & Cole Intl.. It received FDA 510(k) clearance on 1986-05-30 under 510(k) number K861943. The device is classified under product code IQC. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PCI CUSTOM DESIGN SERIES?

PCI CUSTOM DESIGN SERIES is a medical device that received FDA 510(k) clearance on 1986-05-30. The listed applicant is Poston & Cole Intl.. The 510(k) number is K861943.

When did PCI CUSTOM DESIGN SERIES receive FDA 510(k) clearance?

PCI CUSTOM DESIGN SERIES received FDA 510(k) clearance on 1986-05-30, under 510(k) number K861943.

Who is the listed applicant for PCI CUSTOM DESIGN SERIES?

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

What is the FDA product code for PCI CUSTOM DESIGN SERIES?

The FDA product code for PCI CUSTOM DESIGN SERIES is IQC.

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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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