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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K011297
Device Name NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET
Applicant
NIPRO MEDICAL CORP.
1384 COPPERFIELD COURT
LEXINGTON,  KY  40514 -1268
Applicant Contact KAELYN B HADLEY
Correspondent
NIPRO MEDICAL CORP.
1384 COPPERFIELD COURT
LEXINGTON,  KY  40514 -1268
Correspondent Contact KAELYN B HADLEY
Regulation Number880.5200
Classification Product Code
FOZ  
Subsequent Product Code
FMI  
Date Received04/30/2001
Decision Date 06/20/2001
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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