FDA 510(k)

BIOPOLAR BUTTON ELECTRODE, WL 150MM, W/SUCTION APPLICATOR/WL 280MM, W/SUCTION APPLICATOR(8801.451

K-Number: K973295 · 1997-11-26

ApplicantRichard Wolf Medical Instruments Corp.

Decision Date1997-11-26

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BIOPOLAR BUTTON ELECTRODE, WL 150MM, W/SUCTION APPLICATOR/WL 280MM, W/SUCTION APPLICATOR(8801.451 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 1997-11-26 under 510(k) number K973295. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPOLAR BUTTON ELECTRODE, WL 150MM, W/SUCTION APPLICATOR/WL 280MM, W/SUCTION APPLICATOR(8801.451?

BIOPOLAR BUTTON ELECTRODE, WL 150MM, W/SUCTION APPLICATOR/WL 280MM, W/SUCTION APPLICATOR(8801.451 is a medical device that received FDA 510(k) clearance on 1997-11-26. The listed applicant is Richard Wolf Medical Instruments Corp.. The 510(k) number is K973295.

When did BIOPOLAR BUTTON ELECTRODE, WL 150MM, W/SUCTION APPLICATOR/WL 280MM, W/SUCTION APPLICATOR(8801.451 receive FDA 510(k) clearance?

BIOPOLAR BUTTON ELECTRODE, WL 150MM, W/SUCTION APPLICATOR/WL 280MM, W/SUCTION APPLICATOR(8801.451 received FDA 510(k) clearance on 1997-11-26, under 510(k) number K973295.

Who is the listed applicant for BIOPOLAR BUTTON ELECTRODE, WL 150MM, W/SUCTION APPLICATOR/WL 280MM, W/SUCTION APPLICATOR(8801.451?

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 BIOPOLAR BUTTON ELECTRODE, WL 150MM, W/SUCTION APPLICATOR/WL 280MM, W/SUCTION APPLICATOR(8801.451?

The FDA product code for BIOPOLAR BUTTON ELECTRODE, WL 150MM, W/SUCTION APPLICATOR/WL 280MM, W/SUCTION APPLICATOR(8801.451 is GEI.

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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.