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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Trocar, Gastro-Urology
510(k) Number K944104
Device Name GABRIS LAPAROSCOPIC SURGICAL KITS
Applicant
Gabris Surgical Corp.
1432 N. Great Neck Rd.,
Suite 204
Virginia Beach,  VA  23454
Applicant Contact KEN BELTRAN
Correspondent
Gabris Surgical Corp.
1432 N. Great Neck Rd.,
Suite 204
Virginia Beach,  VA  23454
Correspondent Contact KEN BELTRAN
Regulation Number876.5090
Classification Product Code
FBQ  
Date Received08/23/1994
Decision Date 09/13/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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