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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 K011381
Device Name HUMMER IV MICRODEBRIDER SYSTEM
Applicant
Stryker Instruments
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Applicant Contact ROBIN L ROWE
Correspondent
Stryker Instruments
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Correspondent Contact ROBIN L ROWE
Regulation Number874.4250
Classification Product Code
ERL  
Date Received05/07/2001
Decision Date 05/25/2001
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
Recalls CDRH Recalls
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