FDA 510(k)

WIRE

K-Number: K841628 · 1984-07-23

Decision Date1984-07-23

Product CodeHXN

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Plastafil, Inc.. It received FDA 510(k) clearance on 1984-07-23 under 510(k) number K841628. The device is classified under product code HXN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WIRE?

WIRE is a medical device that received FDA 510(k) clearance on 1984-07-23. The listed applicant is Plastafil, Inc.. The 510(k) number is K841628.

When did WIRE receive FDA 510(k) clearance?

WIRE received FDA 510(k) clearance on 1984-07-23, under 510(k) number K841628.

Who is the listed applicant for WIRE?

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

What is the FDA product code for WIRE?

The FDA product code for WIRE is HXN.

Other records listing Plastafil, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K841621BACK RADIUS CUTTER K841620FRONT RADIUS CUTTER K841625HOOK K841617STROVER HOOK K841626PUNCH K841629DRILL BIT

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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.