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FDA 510(k)

LL100 CRYOSURGICAL SYSTEM

K-Number: K803311 · 1981-02-04

ApplicantWallach Surgical Devices, Inc.
Decision Date1981-02-04
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LL100 CRYOSURGICAL SYSTEM 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 1981-02-04 under 510(k) number K803311. 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 LL100 CRYOSURGICAL SYSTEM?

LL100 CRYOSURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 1981-02-04. The listed applicant is Wallach Surgical Devices, Inc.. The 510(k) number is K803311.

When did LL100 CRYOSURGICAL SYSTEM receive FDA 510(k) clearance?

LL100 CRYOSURGICAL SYSTEM received FDA 510(k) clearance on 1981-02-04, under 510(k) number K803311.

Who is the listed applicant for LL100 CRYOSURGICAL SYSTEM?

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 LL100 CRYOSURGICAL SYSTEM?

The FDA product code for LL100 CRYOSURGICAL SYSTEM is GEH.

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Other records listing Wallach Surgical Devices, Inc. as applicant

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Related Devices (Code: GEH)

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K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex MedicalK261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex MedicalK261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbHK253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbHK252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V.K260377XSense Cryoablation System with CryoProbesIceCure Medical , Ltd.

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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