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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K000714
Device Name VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD COLLECTION SET
Applicant
Med-Pro Technologies, Inc.
962 Allegro Ln.
Appollo Beach,  FL  33572
Applicant Contact ART WARD
Correspondent
Med-Pro Technologies, Inc.
962 Allegro Ln.
Appollo Beach,  FL  33572
Correspondent Contact ART WARD
Regulation Number880.5570
Classification Product Code
FMI  
Subsequent Product Code
JKA  
Date Received03/02/2000
Decision Date 12/21/2000
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
Recalls CDRH Recalls
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