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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K042486
Device Name PROCEDUR 10 SYRINGE DEVICE
Applicant
Avanca Medical Devices, Inc.
12200 Academy Rd. NE, # 931
Albuquerque,  NM  87111
Applicant Contact FRANK FERGUSON
Correspondent
Avanca Medical Devices, Inc.
12200 Academy Rd. NE, # 931
Albuquerque,  NM  87111
Correspondent Contact FRANK FERGUSON
Regulation Number880.5860
Classification Product Code
FMF  
Date Received09/13/2004
Decision Date 01/21/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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