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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hood, surgical
510(k) Number K140588
Device Name FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS
Applicant
STRYKER CORPORATION
4100 E. MILHAM AVE
KALAMAZOO,  MI  49001
Applicant Contact JULIA HELGESON
Correspondent
STRYKER CORPORATION
4100 E. MILHAM AVE
KALAMAZOO,  MI  49001
Correspondent Contact JULIA HELGESON
Regulation Number878.4040
Classification Product Code
FXY  
Date Received03/07/2014
Decision Date 06/26/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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