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FDA 510(k)

BIOMECHANIC LOW-PROFILE CABLE SYSTEM

K-Number: K951844 · 1995-07-13

ApplicantBiomechanic, Inc.
Decision Date1995-07-13
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

BIOMECHANIC LOW-PROFILE CABLE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomechanic, Inc.. It received FDA 510(k) clearance on 1995-07-13 under 510(k) number K951844. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the BIOMECHANIC LOW-PROFILE CABLE SYSTEM?

BIOMECHANIC LOW-PROFILE CABLE SYSTEM is a medical device that received FDA 510(k) clearance on 1995-07-13. The listed applicant is Biomechanic, Inc.. The 510(k) number is K951844.

When did BIOMECHANIC LOW-PROFILE CABLE SYSTEM receive FDA 510(k) clearance?

BIOMECHANIC LOW-PROFILE CABLE SYSTEM received FDA 510(k) clearance on 1995-07-13, under 510(k) number K951844.

Who is the listed applicant for BIOMECHANIC LOW-PROFILE CABLE SYSTEM?

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

What is the FDA product code for BIOMECHANIC LOW-PROFILE CABLE SYSTEM?

The FDA product code for BIOMECHANIC LOW-PROFILE CABLE SYSTEM is JDQ.

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Related Devices (Code: JDQ)

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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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