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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 K954774
Device Name SHIELDED TROCAR (OBTURATOR)
Applicant
Gabris Surgical Corp.
1432 N. Great Neck Rd.,
Suite 204
Virginia Beach,  VA  23454
Applicant Contact BARBARA E KENNY
Correspondent
Gabris Surgical Corp.
1432 N. Great Neck Rd.,
Suite 204
Virginia Beach,  VA  23454
Correspondent Contact BARBARA E KENNY
Regulation Number884.1720
Classification Product Code
HET  
Date Received10/17/1995
Decision Date 06/07/1996
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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