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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 K990390
Device Name HEPARIN IV FLUSH SYRINGE, 10 U/ML \
Applicant
ROCAP DIV. OF SABRATEK CORP.
1629 PRIME COURT
BUILDING 100
ORLANDO,  FL  32809
Applicant Contact AVIA TONEY
Correspondent
ROCAP DIV. OF SABRATEK CORP.
1629 PRIME COURT
BUILDING 100
ORLANDO,  FL  32809
Correspondent Contact AVIA TONEY
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received02/09/1999
Decision Date 12/10/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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