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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name heater, perineal, direct contact
510(k) Number K921885
Device Name E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES
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 Number884.5390
Classification Product Code
HGZ  
Date Received04/21/1992
Decision Date 03/25/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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