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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Blade, Scalpel
510(k) Number K932998
Device Name EASY-ON
Applicant
Devon Industries, Inc.
9530 De Soto Ave.
Chatsworth,  CA  91311
Applicant Contact RUDY GABA
Correspondent
Devon Industries, Inc.
9530 De Soto Ave.
Chatsworth,  CA  91311
Correspondent Contact RUDY GABA
Regulation Number878.4800
Classification Product Code
GES  
Date Received06/18/1993
Decision Date 08/18/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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