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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bath, Paraffin
510(k) Number K991427
Device Name PARAMED PARAFFIN WARMER
Applicant
Divi Intl. Co.
12188 SW 128th St.
Miami,  FL  33186
Applicant Contact MIKE VIDAL
Correspondent
Divi Intl. Co.
12188 SW 128th St.
Miami,  FL  33186
Correspondent Contact MIKE VIDAL
Regulation Number890.5110
Classification Product Code
IMC  
Date Received04/23/1999
Decision Date 08/13/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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