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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laryngoscope, Endoscope
510(k) Number K930496
Device Name GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS
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 Number876.1500
Classification Product Code
GCI  
Date Received02/01/1993
Decision Date 04/20/1993
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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