FDA 510(k) Application Details - K915848

Device Classification Name Driver, Wire, And Bone Drill, Manual

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510(K) Number K915848
Device Name Driver, Wire, And Bone Drill, Manual
Applicant SENSORMEDICS CORP.
22705 SAVI RANCH PKWY.
YORBA LINDA, CA US
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Contact PAUL L KITTINGER
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Regulation Number 872.4120

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Classification Product Code DZJ
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Date Received 12/26/1991
Decision Date 10/28/1992
Decision SE - Substantially Equivalent
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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