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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 K883866
Device Name NEOSOFT UMBILICAL VESSEL CATHETER
Applicant
Menlo Care, Inc.
1053 E. Meadow Cir.
Palo Alto,  CA  94303
Applicant Contact COLIN J NICHOLS
Correspondent
Menlo Care, Inc.
1053 E. Meadow Cir.
Palo Alto,  CA  94303
Correspondent Contact COLIN J NICHOLS
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received09/13/1988
Decision Date 11/21/1988
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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