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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stopcock, I.V. Set
510(k) Number K870261
Device Name VIGGO EXACTA PRESSURE MONITORING SYSTEM
Applicant
Ohmeda Medical
2007 Pan Am Cir.
Tampa,  FL  33702
Applicant Contact BRIM, PH.D.
Correspondent
Ohmeda Medical
2007 Pan Am Cir.
Tampa,  FL  33702
Correspondent Contact BRIM, PH.D.
Regulation Number880.5440
Classification Product Code
FMG  
Date Received12/15/1986
Decision Date 04/01/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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