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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K881767
Device Name VIGGO INSUFLON
Applicant
Ohmeda Medical
2007 Pan Am Cir.
Tampa,  FL  33702
Applicant Contact JILL PHILLIPS
Correspondent
Ohmeda Medical
2007 Pan Am Cir.
Tampa,  FL  33702
Correspondent Contact JILL PHILLIPS
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received04/25/1988
Decision Date 08/24/1988
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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