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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K842351
Device Name STERILE DESIGN-CUSTOM STERILE IV KIT
Applicant
Sterile Design, Inc.
P.O. Box 12100
Oldsmar,  FL  34677
Applicant Contact JOHN C HOFFMAN
Correspondent
Sterile Design, Inc.
P.O. Box 12100
Oldsmar,  FL  34677
Correspondent Contact JOHN C HOFFMAN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/15/1984
Decision Date 10/15/1984
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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