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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 K930129
Device Name ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETER
Applicant
Arrow Intl., Inc.
P.O. Box 12888
3000 Bernville Rd.
Reading,  PA  19612
Applicant Contact THOMAS D NICKEL
Correspondent
Arrow Intl., Inc.
P.O. Box 12888
3000 Bernville Rd.
Reading,  PA  19612
Correspondent Contact THOMAS D NICKEL
Regulation Number880.5970
Classification Product Code
LJS  
Date Received01/12/1993
Decision Date 03/28/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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
Recalls CDRH Recalls
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