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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extractor, Vacuum, Fetal
510(k) Number K043614
Device Name VACULINK, MODEL VCL 3000
Applicant
Medevco, Inc.
2300 Mcdermott Rd.
# 200-207
Plano,  TX  75025
Applicant Contact KRISTA OAKES
Correspondent
Medevco, Inc.
2300 Mcdermott Rd.
# 200-207
Plano,  TX  75025
Correspondent Contact KRISTA OAKES
Regulation Number884.4340
Classification Product Code
HDB  
Subsequent Product Code
HGM  
Date Received12/30/2004
Decision Date 04/14/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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