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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 K926405
Device Name .9% NORMAL SALINE TUBE/STERILE WATER TUBE
Applicant
Gam-Med Packaging Corp.
Law Offices Mckenna & Cuneo
1575 Eye St., NW
Washington,  DC  20005
Applicant Contact RICHARD M MANTHEI
Correspondent
Gam-Med Packaging Corp.
Law Offices Mckenna & Cuneo
1575 Eye St., NW
Washington,  DC  20005
Correspondent Contact RICHARD M MANTHEI
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received12/21/1992
Decision Date 02/03/1994
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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