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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 K914923
Device Name UNISURGE DISPOSABLE TROCAR
Applicant
Unisurge, Inc.
1963 Rock St.
Suite #17
Mountain View,  CA  94043
Applicant Contact CHARLES L ROSE
Correspondent
Unisurge, Inc.
1963 Rock St.
Suite #17
Mountain View,  CA  94043
Correspondent Contact CHARLES L ROSE
Regulation Number884.1720
Classification Product Code
HET  
Date Received11/04/1991
Decision Date 09/21/1992
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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