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FDA 510(k)

WALLACH ULTRA FREEZE

K-Number: K935010 · 1994-02-09

ApplicantWallach Surgical Devices, Inc.
Decision Date1994-02-09
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WALLACH ULTRA FREEZE 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 1994-02-09 under 510(k) number K935010. 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 ULTRA FREEZE?

WALLACH ULTRA FREEZE is a medical device that received FDA 510(k) clearance on 1994-02-09. The listed applicant is Wallach Surgical Devices, Inc.. The 510(k) number is K935010.

When did WALLACH ULTRA FREEZE receive FDA 510(k) clearance?

WALLACH ULTRA FREEZE received FDA 510(k) clearance on 1994-02-09, under 510(k) number K935010.

Who is the listed applicant for WALLACH ULTRA FREEZE?

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 ULTRA FREEZE?

The FDA product code for WALLACH ULTRA FREEZE 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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