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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stand, Infusion
510(k) Number K950367
Device Name IV SHUTTLE
Applicant
Equipment Concepts, Inc.
3104 E. Camelback Rd.,
Suite 547
Phoenix,  AZ  85016
Applicant Contact PATRICK S PASULKA
Correspondent
Equipment Concepts, Inc.
3104 E. Camelback Rd.,
Suite 547
Phoenix,  AZ  85016
Correspondent Contact PATRICK S PASULKA
Regulation Number880.6990
Classification Product Code
FOX  
Date Received01/31/1995
Decision Date 04/26/1995
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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