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FDA 510(k)

ACUMED TENSION BAND PIN

K-Number: K964500 · 1996-12-09

ApplicantAcu Med, Inc.
Decision Date1996-12-09
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUMED TENSION BAND PIN is the device name listed in this FDA 510(k) record. The listed applicant is Acu Med, Inc.. It received FDA 510(k) clearance on 1996-12-09 under 510(k) number K964500. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUMED TENSION BAND PIN?

ACUMED TENSION BAND PIN is a medical device that received FDA 510(k) clearance on 1996-12-09. The listed applicant is Acu Med, Inc.. The 510(k) number is K964500.

When did ACUMED TENSION BAND PIN receive FDA 510(k) clearance?

ACUMED TENSION BAND PIN received FDA 510(k) clearance on 1996-12-09, under 510(k) number K964500.

Who is the listed applicant for ACUMED TENSION BAND PIN?

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

What is the FDA product code for ACUMED TENSION BAND PIN?

The FDA product code for ACUMED TENSION BAND PIN is HTY.

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Other records listing Acu Med, 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.

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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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