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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Replacement, Ossicular Prosthesis, Total
510(k) Number K993583
Device Name ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM
Applicant
Stryker Corp.
4100 E. Milham Ave.
Kalamazoo,  MI  49001 -6197
Applicant Contact NICOLE PETTY
Correspondent
Stryker Corp.
4100 E. Milham Ave.
Kalamazoo,  MI  49001 -6197
Correspondent Contact NICOLE PETTY
Regulation Number874.3495
Classification Product Code
ETA  
Subsequent Product Code
ETB  
Date Received10/22/1999
Decision Date 11/10/1999
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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