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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 K944114
Device Name PHLEBOTOMY UNIT SHARPS A GATOR
Applicant
Devon Industries, Inc.
9530 De Soto Ave.
Chatsworth,  CA  91311
Applicant Contact GEORGE AUSTRIA
Correspondent
Devon Industries, Inc.
9530 De Soto Ave.
Chatsworth,  CA  91311
Correspondent Contact GEORGE AUSTRIA
Regulation Number880.5570
Classification Product Code
FMI  
Date Received08/23/1994
Decision Date 12/02/1994
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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