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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K961088
Device Name NON-CORING NEEDLE
Applicant
Arrow Intl., Inc.
1600 Providence Hwy.
Walpole,  MA  02081
Applicant Contact RICHARD J CLARK
Correspondent
Arrow Intl., Inc.
1600 Providence Hwy.
Walpole,  MA  02081
Correspondent Contact RICHARD J CLARK
Regulation Number880.5570
Classification Product Code
FMI  
Date Received03/19/1996
Decision Date 07/02/1996
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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