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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
510(k) Number K901165
Device Name MODULAR FLEXIBLE DRILLING SYSTEM
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 Number878.4820
Classification Product Code
HWE  
Date Received03/13/1990
Decision Date 06/13/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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