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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K970789
Device Name SAFE-CONNECT VIAL DISPENSING SPIKE
Applicant
Faulding Medical Device Co.
8777 E. Via De Ventura,
Suite 225
Scottsdale,  AZ  85258
Applicant Contact BRUCE CRANEY
Correspondent
Faulding Medical Device Co.
8777 E. Via De Ventura,
Suite 225
Scottsdale,  AZ  85258
Correspondent Contact BRUCE CRANEY
Regulation Number880.5440
Classification Product Code
LHI  
Date Received03/04/1997
Decision Date 05/01/1997
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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