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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name light, surgical, fiberoptic
510(k) Number K122637
Model 48089999
Device Name LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999
Original Applicant
STRYKER SPINE
2 pearl court
allendale,  NJ  07401
Original Contact tina mornak
Regulation Number878.4580
Classification Product Code
FST  
Date Received08/29/2012
Decision Date 11/01/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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