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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K032150
Device Name SAFETY-MULTIFLY
Applicant
Sarstedt, Inc.
1025 St. James Church Rd.
P.O. Box 468
Newton,  NC  28658
Applicant Contact PETER RUMSWINKEL
Correspondent
Sarstedt, Inc.
1025 St. James Church Rd.
P.O. Box 468
Newton,  NC  28658
Correspondent Contact PETER RUMSWINKEL
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
JKA  
Date Received07/14/2003
Decision Date 09/12/2003
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
Predetermined Change
Control Plan Authorized		 No
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