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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, gynecologic (and accessories)
510(k) Number K931771
Device Name BIRTCHER ENDOSCOPIC CORKSCREW
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 Number884.1720
Classification Product Code
HET  
Date Received04/09/1993
Decision Date 04/25/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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