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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 K930915
Device Name FLUORI METHANE SS- A VAPOCOOLANT/SKIN REF. DEVICE
Applicant
Gebauer Co.
1920 N. St. NW
Washington,  DC  20036
Applicant Contact NORMAN PHILION
Correspondent
Gebauer Co.
1920 N. St. NW
Washington,  DC  20036
Correspondent Contact NORMAN PHILION
Classification Product Code
MLY  
Date Received02/23/1993
Decision Date 09/29/1994
Decision Substantially Equivalent (SESE)
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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