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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 K032671
Device Name GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07
Applicant
GEBAUER CO.
9410 ST. CATHERINE AVE.
CLEVELAND,  OH  44104
Applicant Contact AMY J PAUKOVITS
Correspondent
GEBAUER CO.
9410 ST. CATHERINE AVE.
CLEVELAND,  OH  44104
Correspondent Contact AMY J PAUKOVITS
Classification Product Code
MLY  
Date Received08/29/2003
Decision Date 03/17/2004
Decision Substantially Equivalent (SESE)
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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