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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 K150109
Device Name Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology
Applicant
Arrow International (A Subsidiary of Teleflex, Inc.)
2400 Bernville Rd.
Reading,  PA  19605
Applicant Contact Karl J Nittinger
Correspondent
Arrow International (A Subsidiary of Teleflex, Inc.)
2400 Bernville Rd.
Reading,  PA  19605
Correspondent Contact Karl J Nittinger
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received01/20/2015
Decision Date 06/05/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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