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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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