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FDA 510(k)

IRRIGATION/SUCTION HANDLE AND SHEATH

K-Number: K963757 · 1996-11-26

ApplicantRichard Wolf Medical Instruments Corp.
Decision Date1996-11-26
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

IRRIGATION/SUCTION HANDLE AND SHEATH 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 1996-11-26 under 510(k) number K963757. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRRIGATION/SUCTION HANDLE AND SHEATH?

IRRIGATION/SUCTION HANDLE AND SHEATH is a medical device that received FDA 510(k) clearance on 1996-11-26. The listed applicant is Richard Wolf Medical Instruments Corp.. The 510(k) number is K963757.

When did IRRIGATION/SUCTION HANDLE AND SHEATH receive FDA 510(k) clearance?

IRRIGATION/SUCTION HANDLE AND SHEATH received FDA 510(k) clearance on 1996-11-26, under 510(k) number K963757.

Who is the listed applicant for IRRIGATION/SUCTION HANDLE AND SHEATH?

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 IRRIGATION/SUCTION HANDLE AND SHEATH?

The FDA product code for IRRIGATION/SUCTION HANDLE AND SHEATH is EOB.

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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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