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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name drills, burrs, trephines & accessories (simple, powered)
510(k) Number K943541
Device Name 75K STAIGHT DRILL
Applicant
STRYKER CORP.
4100 E MILHAM AVE.
PORTAGE,  MI  49002 -9704
Applicant Contact TAMMY LOUNDS
Correspondent
STRYKER CORP.
4100 E MILHAM AVE.
PORTAGE,  MI  49002 -9704
Correspondent Contact TAMMY LOUNDS
Regulation Number882.4310
Classification Product Code
HBE  
Date Received07/22/1994
Decision Date 05/18/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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