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FDA 510(k)

WALLACH COLD SOAKER

K-Number: K910491 · 1991-05-21

ApplicantWallach Surgical Devices, Inc.
Decision Date1991-05-21
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WALLACH COLD SOAKER is the device name listed in this FDA 510(k) record. The listed applicant is Wallach Surgical Devices, Inc.. It received FDA 510(k) clearance on 1991-05-21 under 510(k) number K910491. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WALLACH COLD SOAKER?

WALLACH COLD SOAKER is a medical device that received FDA 510(k) clearance on 1991-05-21. The listed applicant is Wallach Surgical Devices, Inc.. The 510(k) number is K910491.

When did WALLACH COLD SOAKER receive FDA 510(k) clearance?

WALLACH COLD SOAKER received FDA 510(k) clearance on 1991-05-21, under 510(k) number K910491.

Who is the listed applicant for WALLACH COLD SOAKER?

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

What is the FDA product code for WALLACH COLD SOAKER?

The FDA product code for WALLACH COLD SOAKER is GEH.

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Other records listing Wallach Surgical Devices, 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.

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Related Devices (Code: GEH)

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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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