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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 K024286
Device Name GYRUS OPEN FORCEPS
Applicant
Gyrus Medical, Inc.
6655 Wedgwood Rd., # 105
Minneapolis,  MN  55311 -3602
Applicant Contact MARK JENSEN
Correspondent
Gyrus Medical, Inc.
6655 Wedgwood Rd., # 105
Minneapolis,  MN  55311 -3602
Correspondent Contact MARK JENSEN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/23/2002
Decision Date 11/17/2003
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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