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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name I.V. Start Kit
510(k) Number K951167
Device Name EMS I.V. START KIT
Applicant
Emergency Medical Supply, Inc.
P.O. Box 99
Shepherdsville,  KY  40165
Applicant Contact WILLIAM MARTIN JR.
Correspondent
Emergency Medical Supply, Inc.
P.O. Box 99
Shepherdsville,  KY  40165
Correspondent Contact WILLIAM MARTIN JR.
Regulation Number880.5200
Classification Product Code
LRS  
Date Received03/14/1995
Decision Date 05/16/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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