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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name vapocoolant device
510(k) Number K002596
Device Name GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09
Applicant
GEBAUER CO.
9410 ST. CATHERINE AVE.
CLEVELAND,  OH  44104
Applicant Contact DENISE E SPELLMAN
Correspondent
GEBAUER CO.
9410 ST. CATHERINE AVE.
CLEVELAND,  OH  44104
Correspondent Contact DENISE E SPELLMAN
Classification Product Code
MLY  
Date Received08/21/2000
Decision Date 02/15/2001
Decision Substantially Equivalent (SESE)
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
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