WA1000

Unit, Cryosurgical, Accessories

WALLACH SURGICAL DEVICES, INC.

The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Wa1000.

Pre-market Notification Details

Device IDK813024
510k NumberK813024
Device Name:WA1000
ClassificationUnit, Cryosurgical, Accessories
Applicant WALLACH SURGICAL DEVICES, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeGEH  
CFR Regulation Number878.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-10-28
Decision Date1981-12-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00888937019902 K813024 000
00888937014037 K813024 000
00888937014020 K813024 000
00888937009873 K813024 000
00888937009866 K813024 000

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