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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 K922206
Device Name SURGISTAT
Applicant
VALLEYLAB, INC.
5920 LONGBOW DR.
BOULDER,  CO  80301
Applicant Contact PEGGY WALLINE
Correspondent
VALLEYLAB, INC.
5920 LONGBOW DR.
BOULDER,  CO  80301
Correspondent Contact PEGGY WALLINE
Regulation Number884.4120
Classification Product Code
HGI  
Date Received05/12/1992
Decision Date 09/07/1993
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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