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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 K931729
Device Name I.V. START KIT
Applicant
CARAPACE, INC.
2701 W CONCORD ST.
BROKEN ARROW,  OK  74012
Applicant Contact JERRY W MYERS
Correspondent
CARAPACE, INC.
2701 W CONCORD ST.
BROKEN ARROW,  OK  74012
Correspondent Contact JERRY W MYERS
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received04/07/1993
Decision Date 02/22/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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