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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 K945197
Device Name THE SHARPS COLLECTION AND DISPOSAL SYSTEM
Applicant
Devon Industries, Inc.
9530 De Soto Ave.
Chatsworth,  CA  91311
Applicant Contact GEORGIA AUSTRIA
Correspondent
Devon Industries, Inc.
9530 De Soto Ave.
Chatsworth,  CA  91311
Correspondent Contact GEORGIA AUSTRIA
Regulation Number880.5570
Classification Product Code
MMK  
Date Received10/24/1994
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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