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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Pressure, Intrauterine
510(k) Number K943989
Device Name LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT
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 Number884.2700
Classification Product Code
HFO  
Date Received08/16/1994
Decision Date 09/12/1994
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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