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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 K021395
Device Name MODIFICATION TO 30 EXTENSION SET
Applicant
CHURCHILL MEDICAL SYSTEMS, INC.
87 VENTURE DR.
DOVER,  NH  03820
Applicant Contact KEVIN PALUCH
Correspondent
CHURCHILL MEDICAL SYSTEMS, INC.
87 VENTURE DR.
DOVER,  NH  03820
Correspondent Contact KEVIN PALUCH
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/02/2002
Decision Date 05/13/2002
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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