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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 K844004
Device Name ESCHMANN TDB50 BIPOLAR COAGULATION
Applicant
Storz Instrument Co.
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Applicant Contact NILES ROSS
Correspondent
Storz Instrument Co.
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Correspondent Contact NILES ROSS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/12/1984
Decision Date 12/12/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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