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FDA 510(k)

STATIC STRENGTH TESTER

K-Number: K862096 · 1986-07-15

ApplicantLowcountry Orthopaedic Assoc., P.A.
Decision Date1986-07-15
Product CodeIKK
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

STATIC STRENGTH TESTER is the device name listed in this FDA 510(k) record. The listed applicant is Lowcountry Orthopaedic Assoc., P.A.. It received FDA 510(k) clearance on 1986-07-15 under 510(k) number K862096. The device is classified under product code IKK. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STATIC STRENGTH TESTER?

STATIC STRENGTH TESTER is a medical device that received FDA 510(k) clearance on 1986-07-15. The listed applicant is Lowcountry Orthopaedic Assoc., P.A.. The 510(k) number is K862096.

When did STATIC STRENGTH TESTER receive FDA 510(k) clearance?

STATIC STRENGTH TESTER received FDA 510(k) clearance on 1986-07-15, under 510(k) number K862096.

Who is the listed applicant for STATIC STRENGTH TESTER?

The FDA 510(k) record lists Lowcountry Orthopaedic Assoc., P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STATIC STRENGTH TESTER?

The FDA product code for STATIC STRENGTH TESTER is IKK.

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Related Devices (Code: IKK)

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

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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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