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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Sharps
510(k) Number K964387
Device Name POINT OF USE II SHARPS-A-GATOR
Applicant
Graphic Controls Corp.
9530 De Soto Ave.
Chatsworth,  CA  91311
Applicant Contact GEORGE AUSTRIA
Correspondent
Graphic Controls Corp.
9530 De Soto Ave.
Chatsworth,  CA  91311
Correspondent Contact GEORGE AUSTRIA
Regulation Number880.5570
Classification Product Code
MMK  
Date Received11/04/1996
Decision Date 03/27/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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