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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 K952681
Device Name STRYKER HUMMER II MICRODEBRIDER SYSTEM
Applicant
Stryker Endoscopy
210 Baypointe Pkwy.
San Jose,  CA  95134
Applicant Contact JEFF KABLIK
Correspondent
Stryker Endoscopy
210 Baypointe Pkwy.
San Jose,  CA  95134
Correspondent Contact JEFF KABLIK
Regulation Number874.4250
Classification Product Code
ERL  
Date Received06/12/1995
Decision Date 07/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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