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FDA 510(k)

POLYCORD II

K-Number: K880303 · 1988-12-05

ApplicantTechnetics, Inc.
Decision Date1988-12-05
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POLYCORD II is the device name listed in this FDA 510(k) record. The listed applicant is Technetics, Inc.. It received FDA 510(k) clearance on 1988-12-05 under 510(k) number K880303. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYCORD II?

POLYCORD II is a medical device that received FDA 510(k) clearance on 1988-12-05. The listed applicant is Technetics, Inc.. The 510(k) number is K880303.

When did POLYCORD II receive FDA 510(k) clearance?

POLYCORD II received FDA 510(k) clearance on 1988-12-05, under 510(k) number K880303.

Who is the listed applicant for POLYCORD II?

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

What is the FDA product code for POLYCORD II?

The FDA product code for POLYCORD II is DSH.

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Related Devices (Code: DSH)

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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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