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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K113170
Device Name CERVICAL PLATE
Applicant
Eisertech, LLC
2555 Front St.
San Diego,  CA  92103
Applicant Contact LUKAS EISERMANN
Correspondent
Eisertech, LLC
2555 Front St.
San Diego,  CA  92103
Correspondent Contact LUKAS EISERMANN
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received10/27/2011
Decision Date 04/06/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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