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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
510(k) Number K990038
Device Name HUMMER TRAK SYSTEM
Applicant
Stryker Endoscopy
2590 Walsh Ave.
Santa Clara,  CA  95051 -4085
Applicant Contact DAVID HIMES
Correspondent
Stryker Endoscopy
2590 Walsh Ave.
Santa Clara,  CA  95051 -4085
Correspondent Contact DAVID HIMES
Regulation Number874.4250
Classification Product Code
ERL  
Date Received01/06/1999
Decision Date 02/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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