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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 K932779
Device Name BIRTCHER SWIVEL GRIP LAPAROSCOPIC PROBES & ACCESS.
Applicant
Birtcher Medical Systems, Inc.
1435-J Henry Brennan Dr.
El Paso,  TX  79936
Applicant Contact EILEEN M ANDERSON
Correspondent
Birtcher Medical Systems, Inc.
1435-J Henry Brennan Dr.
El Paso,  TX  79936
Correspondent Contact EILEEN M ANDERSON
Regulation Number884.1720
Classification Product Code
HET  
Subsequent Product Code
KNF  
Date Received06/08/1993
Decision Date 03/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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