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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K925824
Device Name SOLOS FAN RETRACTORS
Applicant
Birtcher Medical Systems, Inc.
50 Technology Dr.
Irvine,  CA  92718
Applicant Contact GUSTAVUS D BOCK
Correspondent
Birtcher Medical Systems, Inc.
50 Technology Dr.
Irvine,  CA  92718
Correspondent Contact GUSTAVUS D BOCK
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/17/1992
Decision Date 03/01/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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