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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 K942944
Device Name IRRIGATION/BIPOLAR SET
Applicant
Surgin Surgical Instrumentation, Inc.
14762 Bentley Cir.
Tustin,  CA  92680
Applicant Contact DON W HARR
Correspondent
Surgin Surgical Instrumentation, Inc.
14762 Bentley Cir.
Tustin,  CA  92680
Correspondent Contact DON W HARR
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/22/1994
Decision Date 09/27/1994
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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