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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 K953548
Device Name LAPAROSCOPIC SURGICAL INSTRUMENT
Applicant
Gabris Surgical Corp.
1432 N. Great Neck Rd.,
Suite 204
Virginia Beach,  VA  23454
Applicant Contact KENNETH A BELTRAN
Correspondent
Gabris Surgical Corp.
1432 N. Great Neck Rd.,
Suite 204
Virginia Beach,  VA  23454
Correspondent Contact KENNETH A BELTRAN
Regulation Number884.1720
Classification Product Code
HET  
Date Received07/28/1995
Decision Date 09/19/1995
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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