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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screwdriver
510(k) Number K901166
Device Name DALTON TECHNOLOGY FLEXIBLE SCREWDRIVER
Applicant
Dalton Technology, Inc.
6062 San Fernando Rd.
Glendale,  CA  91202
Applicant Contact JAMES LAFFERTY
Correspondent
Dalton Technology, Inc.
6062 San Fernando Rd.
Glendale,  CA  91202
Correspondent Contact JAMES LAFFERTY
Regulation Number888.4540
Classification Product Code
HXX  
Date Received03/13/1990
Decision Date 06/13/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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