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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 K882025
Device Name MODIFIED EXTRAVAKIT
Applicant
Extravakit, Inc.
209 S. Tucson Blvd., Suite B
Tucson,  AZ  85716
Applicant Contact DORR, PHD
Correspondent
Extravakit, Inc.
209 S. Tucson Blvd., Suite B
Tucson,  AZ  85716
Correspondent Contact DORR, PHD
Regulation Number880.5860
Classification Product Code
FMF  
Date Received05/17/1988
Decision Date 07/27/1988
Decision Substantially Equivalent - With Drug (SESD)
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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