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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrocautery, gynecologic (and accessories)
510(k) Number K921386
Device Name SUOP ELECTRODES FOR EXCISIONAL PROCEDURES
Applicant
SILVER CREEK SURGICAL
1963 ROCK ST.
SUITE 17
MOUNTAIN VIEW,  CA  94043
Applicant Contact CHARLES L ROSE
Correspondent
SILVER CREEK SURGICAL
1963 ROCK ST.
SUITE 17
MOUNTAIN VIEW,  CA  94043
Correspondent Contact CHARLES L ROSE
Regulation Number884.4120
Classification Product Code
HGI  
Date Received03/23/1992
Decision Date 10/08/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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