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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 K931654
Device Name BIRTCHER MAGNETIC RETRIEVER (GS-3100)
Applicant
Birtcher Medical Systems, Inc.
50 Technology Dr.
Irvine,  CA  92718
Applicant Contact GERRYN B ARCE
Correspondent
Birtcher Medical Systems, Inc.
50 Technology Dr.
Irvine,  CA  92718
Correspondent Contact GERRYN B ARCE
Regulation Number884.1720
Classification Product Code
HET  
Date Received04/05/1993
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
Predetermined Change
Control Plan Authorized		 No
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