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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, administration, intravascular
510(k) Number K940689
Device Name WALL IV EXTENSION TUBE
Applicant
WALLA MEDICAL SYSTEMS, INC.
5139 JIMMY CARTER BOULEVARD,
SUITE 103
NORCROSS,  GA  30093
Applicant Contact WILLIAM H WALL
Correspondent
WALLA MEDICAL SYSTEMS, INC.
5139 JIMMY CARTER BOULEVARD,
SUITE 103
NORCROSS,  GA  30093
Correspondent Contact WILLIAM H WALL
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/16/1994
Decision Date 03/22/1994
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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