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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
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