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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 K923653
Device Name NEEDLELESS INJECTION CANNULA
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 Received07/21/1992
Decision Date 05/13/1993
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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