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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, Long-Term Greater Than 30 Days
510(k) Number K042126
Device Name PICC
Applicant
Arrow Intl., Inc.
2400 Bernville Rd.
Reading,  PA  19612
Applicant Contact SUZANNE SCHORLE
Correspondent
Arrow Intl., Inc.
2400 Bernville Rd.
Reading,  PA  19612
Correspondent Contact SUZANNE SCHORLE
Regulation Number880.5970
Classification Product Code
LJS  
Date Received08/06/2004
Decision Date 08/27/2004
Decision SE - With Limitations (SESU)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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