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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 K863606
Device Name BUTTERFLY NON-CORING NEEDLE SET
Applicant
CORMED, INC., SUB. C.R.BARD, INC.
591 MAHAR ST.
MEDINA,  NY  14103
Applicant Contact ANKERUD, JD
Correspondent
CORMED, INC., SUB. C.R.BARD, INC.
591 MAHAR ST.
MEDINA,  NY  14103
Correspondent Contact ANKERUD, JD
Regulation Number880.5570
Classification Product Code
FMI  
Date Received09/16/1986
Decision Date 12/18/1986
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
Recalls CDRH Recalls
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