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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
510(k) Number K962800
Device Name STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES
Applicant
Stryker Instruments
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Applicant Contact DIANE DAVIS
Correspondent
Stryker Instruments
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Correspondent Contact DIANE DAVIS
Regulation Number878.4820
Classification Product Code
HWE  
Subsequent Product Codes
GFA   GFF   HSZ  
Date Received07/18/1996
Decision Date 09/11/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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