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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter, Reprocessed
510(k) Number K042316
Device Name VANGUARD REPROCESSED PULSE OXIMETER SENSORS
Applicant
Vanguard Medical Concepts, Inc.
5307 Great Oak Dr.
Lakeland,  FL  33815
Applicant Contact HEATHER CRAWFORD
Correspondent
Vanguard Medical Concepts, Inc.
5307 Great Oak Dr.
Lakeland,  FL  33815
Correspondent Contact HEATHER CRAWFORD
Regulation Number870.2700
Classification Product Code
NLF  
Date Received08/26/2004
Decision Date 01/06/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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