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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K883242
Device Name EXTRAVAKIT FOR DIMETHYLSULFOXIDE (DMSO)
Applicant
Cancer Technologies, Inc.
C/O Extravakit, Inc.
209 S. Tucson Blvd., Bldg. B
Tucson,  AR  85716
Applicant Contact DORR, PH.D
Correspondent
Cancer Technologies, Inc.
C/O Extravakit, Inc.
209 S. Tucson Blvd., Bldg. B
Tucson,  AR  85716
Correspondent Contact DORR, PH.D
Regulation Number880.5860
Classification Product Code
FMF  
Date Received08/02/1988
Decision Date 10/12/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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