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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 K954887
Device Name STERILE WATER O.9% STERILE SALINE
Applicant
Lockett Medical Corp.
Three Richmond Sq.
Providence,  RI  02906
Applicant Contact DENISE TREACY
Correspondent
Lockett Medical Corp.
Three Richmond Sq.
Providence,  RI  02906
Correspondent Contact DENISE TREACY
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received10/16/1995
Decision Date 01/24/1996
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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