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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, Dc-Powered Motor And Accessory/Attachment
510(k) Number K972367
Device Name STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT
Applicant
STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Applicant Contact MELISSA HARRIGER
Correspondent
STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Correspondent Contact MELISSA HARRIGER
Regulation Number878.4820
Classification Product Code
KIJ  
Date Received06/25/1997
Decision Date 09/04/1997
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
Recalls CDRH Recalls
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