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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K160978
Device Name LITe BIO Delivery System
Applicant
STRYKER CORPORATION
2 PEARL COURT
ALLENDALE,  NJ  07401
Applicant Contact Meriam Gabera
Correspondent
STRYKER CORPORATION
2 PEARL COURT
ALLENDALE,  NJ  07401
Correspondent Contact Meriam Gabera
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/07/2016
Decision Date 07/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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