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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 K984564
Device Name ETHYL CHLORIDE DISPENSER
Applicant
Dukal Corp.
3234 Ella Ln.
New Port Riche,  FL  34655
Applicant Contact ED RASOM
Correspondent
Dukal Corp.
3234 Ella Ln.
New Port Riche,  FL  34655
Correspondent Contact ED RASOM
Classification Product Code
MLY  
Date Received12/23/1998
Decision Date 12/02/1999
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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