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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.
APOLLO BEACH,  FL  33572
Applicant Contact ART WARD
Correspondent
MED-PRO TECHNOLOGIES, INC.
962 ALLEGRO LN.
APOLLO 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
Recalls CDRH Recalls
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