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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 K982029
Device Name SHARPS COLLECTION CONTAINER - SAF-T-SHELL
Applicant
American Medical Mfg., Inc.
9410 Desoto Ave., Unit J
Chatsworth,  CA  91311
Applicant Contact MIKE HOFTMAN
Correspondent
American Medical Mfg., Inc.
9410 Desoto Ave., Unit J
Chatsworth,  CA  91311
Correspondent Contact MIKE HOFTMAN
Regulation Number880.5570
Classification Product Code
FMI  
Date Received06/09/1998
Decision Date 04/06/1999
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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