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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lamp, surgical
510(k) Number K981717
Device Name STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR
Applicant
STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Applicant Contact NICOLE PETTY
Correspondent
STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Correspondent Contact NICOLE PETTY
Regulation Number878.4580
Classification Product Code
FTD  
Date Received05/15/1998
Decision Date 06/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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