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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 K130669
Device Name SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS
Applicant
OLSEN MEDICAL
1927 N. ARTHUR DR.
COLUMBIA CITY,  IN  46725
Applicant Contact DALENE BINKLEY
Correspondent
OLSEN MEDICAL
1927 N. ARTHUR DR.
COLUMBIA CITY,  IN  46725
Correspondent Contact DALENE BINKLEY
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/12/2013
Decision Date 12/06/2013
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
Recalls CDRH Recalls
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