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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Head, Neurosurgical (Skull Clamp)
510(k) Number K874298
Device Name MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME
Applicant
Engineered Orthopedic Technologies, Inc.
114-C Los Molinos
San Clemente,  CA  92672
Applicant Contact ROGER J MALCOLM
Correspondent
Engineered Orthopedic Technologies, Inc.
114-C Los Molinos
San Clemente,  CA  92672
Correspondent Contact ROGER J MALCOLM
Regulation Number882.4460
Classification Product Code
HBL  
Date Received10/20/1987
Decision Date 02/04/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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