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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 K940775
Device Name INJECTION CAP
Applicant
Medron, Inc.
3614 W. 2100 S.
Salt Lake City,  UT  84120
Applicant Contact RON WORTLEY
Correspondent
Medron, Inc.
3614 W. 2100 S.
Salt Lake City,  UT  84120
Correspondent Contact RON WORTLEY
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received02/22/1994
Decision Date 06/15/1994
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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