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FDA 510(k)

AUXILIARY INSTRUMENTS FOR URS

K-Number: K971315 · 1997-09-15

ApplicantRichard Wolf Medical Instruments Corp.
Decision Date1997-09-15
Product CodeFCL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AUXILIARY INSTRUMENTS FOR URS is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corp.. It received FDA 510(k) clearance on 1997-09-15 under 510(k) number K971315. The device is classified under product code FCL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUXILIARY INSTRUMENTS FOR URS?

AUXILIARY INSTRUMENTS FOR URS is a medical device that received FDA 510(k) clearance on 1997-09-15. The listed applicant is Richard Wolf Medical Instruments Corp.. The 510(k) number is K971315.

When did AUXILIARY INSTRUMENTS FOR URS receive FDA 510(k) clearance?

AUXILIARY INSTRUMENTS FOR URS received FDA 510(k) clearance on 1997-09-15, under 510(k) number K971315.

Who is the listed applicant for AUXILIARY INSTRUMENTS FOR URS?

The FDA 510(k) record lists Richard Wolf Medical Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUXILIARY INSTRUMENTS FOR URS?

The FDA product code for AUXILIARY INSTRUMENTS FOR URS is FCL.

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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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