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FDA 510(k)

GUIBOR MICROELECTROLYSIS UNIT 18

K-Number: K851318 · 1985-08-20

ApplicantGalvanic Medical Instruments, Inc.
Decision Date1985-08-20
Product CodeKCW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GUIBOR MICROELECTROLYSIS UNIT 18 is the device name listed in this FDA 510(k) record. The listed applicant is Galvanic Medical Instruments, Inc.. It received FDA 510(k) clearance on 1985-08-20 under 510(k) number K851318. The device is classified under product code KCW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUIBOR MICROELECTROLYSIS UNIT 18?

GUIBOR MICROELECTROLYSIS UNIT 18 is a medical device that received FDA 510(k) clearance on 1985-08-20. The listed applicant is Galvanic Medical Instruments, Inc.. The 510(k) number is K851318.

When did GUIBOR MICROELECTROLYSIS UNIT 18 receive FDA 510(k) clearance?

GUIBOR MICROELECTROLYSIS UNIT 18 received FDA 510(k) clearance on 1985-08-20, under 510(k) number K851318.

Who is the listed applicant for GUIBOR MICROELECTROLYSIS UNIT 18?

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

What is the FDA product code for GUIBOR MICROELECTROLYSIS UNIT 18?

The FDA product code for GUIBOR MICROELECTROLYSIS UNIT 18 is KCW.

Related Clinical Trials

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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Other records listing Galvanic Medical Instruments, Inc. as applicant

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.

K821850GALTEL-18

Related Devices (Code: KCW)

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.

K954031COMPU-BLEND EPILATORR. A. Fischer Co. Corp.K952611STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATIONSterex Electrolysis Intl., Ltd.K945192HAIR REMOVAL SYSTEML.P. Systems Corp.K943928APILUS ELECTROPILDectro Intl., Inc.K943398THE BLENDTONE ROYALEInstantronK943396THE ELITE SPECTRUMInstantron

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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