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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 K011336
Device Name PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK
Applicant
CHURCHILL MEDICAL SYSTEMS, INC.
87 VENTURE DR.
DOVER,  NH  03820
Applicant Contact KEITH PAULCH
Correspondent
CHURCHILL MEDICAL SYSTEMS, INC.
87 VENTURE DR.
DOVER,  NH  03820
Correspondent Contact KEITH PAULCH
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/02/2001
Decision Date 06/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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