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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 K944681
Device Name LECTROSURIGICAL, CUTTING AND COAGULATION AND ACCESSORIES
Applicant
Birtcher Medical Systems, Inc.
50 Technology Dr.
Irvine,  CA  92718
Applicant Contact GERRY B ARCE
Correspondent
Birtcher Medical Systems, Inc.
50 Technology Dr.
Irvine,  CA  92718
Correspondent Contact GERRY B ARCE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/22/1994
Decision Date 12/22/1994
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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