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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number K912129
Device Name DOBBHOFF(R) BIPOLAR HEMOSTATIC PROBE
Applicant
Biosearch Medical Products, Inc.
35 Industrial Pkwy.
P.O. Box 1700
Somerville,  NJ  08876
Applicant Contact MATTHEW W LESNIESKI
Correspondent
Biosearch Medical Products, Inc.
35 Industrial Pkwy.
P.O. Box 1700
Somerville,  NJ  08876
Correspondent Contact MATTHEW W LESNIESKI
Regulation Number876.4300
Classification Product Code
KNS  
Date Received05/14/1991
Decision Date 08/07/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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