MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME

Holder, Head, Neurosurgical (skull Clamp)

ENGINEERED ORTHOPEDIC TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Engineered Orthopedic Technologies, Inc. with the FDA for Malcolm-rand Microneurosurgical Cranio-xray Frame.

Pre-market Notification Details

Device IDK874298
510k NumberK874298
Device Name:MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME
ClassificationHolder, Head, Neurosurgical (skull Clamp)
Applicant ENGINEERED ORTHOPEDIC TECHNOLOGIES, INC. 114-C LOS MOLINOS San Clemente,  CA  92672
ContactRoger J Malcolm
CorrespondentRoger J Malcolm
ENGINEERED ORTHOPEDIC TECHNOLOGIES, INC. 114-C LOS MOLINOS San Clemente,  CA  92672
Product CodeHBL  
CFR Regulation Number882.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-10-20
Decision Date1988-02-04

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