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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
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