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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K020544
Device Name WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA
Applicant
CHURCHILL MEDICAL SYSTEMS, INC.
87 VENTURE DR.
DOVER,  NH  03820
Applicant Contact KEITH PALUCH
Correspondent
CHURCHILL MEDICAL SYSTEMS, INC.
87 VENTURE DR.
DOVER,  NH  03820
Correspondent Contact KEITH PALUCH
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/15/2002
Decision Date 03/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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