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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 K070997
Device Name DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR REUSABLE CABLES, MODEL 5015-XX
Applicant
Pro-Med Instruments GmbH
5450 Lee St., Suite 1
Lehigh Acres,  FL  33971
Applicant Contact EDGAR SCHUELE
Correspondent
Pro-Med Instruments GmbH
5450 Lee St., Suite 1
Lehigh Acres,  FL  33971
Correspondent Contact EDGAR SCHUELE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/09/2007
Decision Date 05/16/2007
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
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