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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 K970644
Device Name AEROQUIP SAFESTART (TM) IV CATH (TM) SYSTEM
Applicant
Aeroquip Medical Products
2323 Green Rd.
Ann Arbor,  MI  48105
Applicant Contact CHRISTINA L THOMAS
Correspondent
Aeroquip Medical Products
2323 Green Rd.
Ann Arbor,  MI  48105
Correspondent Contact CHRISTINA L THOMAS
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received02/20/1997
Decision Date 07/31/1997
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
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