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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 K844654
Device Name SHARP COLLECTION SYSTEM-SHARP-A-GATOR
Applicant
Devon Industries, Inc.
9530 De Soto Ave.
Chatsworth,  CA  91311
Applicant Contact MIKE HOFTMAN
Correspondent
Devon Industries, Inc.
9530 De Soto Ave.
Chatsworth,  CA  91311
Correspondent Contact MIKE HOFTMAN
Regulation Number880.5570
Classification Product Code
MMK  
Date Received11/29/1984
Decision Date 12/12/1984
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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