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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 K860479
Device Name GREEN-LINE BIPOLAR COAGULATION UNIT
Applicant
Grieshaber & Co.
1056 Trenton Rd.
P.O. Box 807
Fallisington,  PA  19054
Applicant Contact JOHN RICHMOND
Correspondent
Grieshaber & Co.
1056 Trenton Rd.
P.O. Box 807
Fallisington,  PA  19054
Correspondent Contact JOHN RICHMOND
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/07/1986
Decision Date 05/01/1986
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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