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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 K925903
Device Name LAPAROSCOPIC 5MM ABC PROBE, MODIFICATION
Applicant
Birtcher Medical Systems, Inc.
50 Technology Dr.
Irvine,  CA  92718
Applicant Contact EILEEN M ANDERSON
Correspondent
Birtcher Medical Systems, Inc.
50 Technology Dr.
Irvine,  CA  92718
Correspondent Contact EILEEN M ANDERSON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/12/1992
Decision Date 12/30/1992
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
Recalls CDRH Recalls
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