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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Fiber Optic, Dental
510(k) Number K871816
Device Name STRYKERSCOPE TM/ORTHOSCOPE TM/STRYKER MINISCOPE TM
Applicant
Stryker Corp.
420 Alcott St.
Kalamazoo,  MI  49001
Applicant Contact HARMON H WOODWORTH
Correspondent
Stryker Corp.
420 Alcott St.
Kalamazoo,  MI  49001
Correspondent Contact HARMON H WOODWORTH
Regulation Number872.4620
Classification Product Code
EAY  
Date Received05/11/1987
Decision Date 08/03/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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