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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 K991514
Device Name GEBAUER'S CHLORIDE FINE NOZZE
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 Received04/30/1999
Decision Date 07/16/1999
Decision Substantially Equivalent (SESE)
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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