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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 STREET, N.W.
WASHINGTON,  DC  20005
Applicant Contact RICHARD M MANTHEI
Correspondent
GAM-MED PACKAGING CORP.
LAW OFFICES MCKENNA & CUNEO
1575 EYE STREET, N.W.
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
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