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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K061660
Device Name STRYKER RF PARALLEL BIPOLAR ADAPTOR CABLE
Applicant
STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Applicant Contact JENNIFER HOFFMAN
Correspondent
STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Correspondent Contact JENNIFER HOFFMAN
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
GXI  
Date Received06/13/2006
Decision Date 10/10/2006
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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