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FDA 510(k)

ADJUSTABLE THERASNORE

K-Number: K973038 · 1997-11-12

ApplicantDistar, Inc.
Decision Date1997-11-12
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ADJUSTABLE THERASNORE is the device name listed in this FDA 510(k) record. The listed applicant is Distar, Inc.. It received FDA 510(k) clearance on 1997-11-12 under 510(k) number K973038. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADJUSTABLE THERASNORE?

ADJUSTABLE THERASNORE is a medical device that received FDA 510(k) clearance on 1997-11-12. The listed applicant is Distar, Inc.. The 510(k) number is K973038.

When did ADJUSTABLE THERASNORE receive FDA 510(k) clearance?

ADJUSTABLE THERASNORE received FDA 510(k) clearance on 1997-11-12, under 510(k) number K973038.

Who is the listed applicant for ADJUSTABLE THERASNORE?

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

What is the FDA product code for ADJUSTABLE THERASNORE?

The FDA product code for ADJUSTABLE THERASNORE is LRK.

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Related Devices (Code: LRK)

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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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