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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, monitoring, perinatal
510(k) Number K013281
Device Name VERSALAB APM
Applicant
NICOLET BIOMEDICAL
6355 JOYCE DR.
GOLDEN,  CO  80403
Applicant Contact DAVID W WAGNER
Correspondent
NICOLET BIOMEDICAL
6355 JOYCE DR.
GOLDEN,  CO  80403
Correspondent Contact DAVID W WAGNER
Regulation Number884.2740
Classification Product Code
HGM  
Date Received10/02/2001
Decision Date 04/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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