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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 K882503
Device Name 30 IV EXTENSION SET W/TWO MALE LUER LOCKS
Applicant
Churchill Medical Systems, Inc.
905 Sheehy Dr.
Horsham,  PA  19044
Applicant Contact JOEL A MARCUS
Correspondent
Churchill Medical Systems, Inc.
905 Sheehy Dr.
Horsham,  PA  19044
Correspondent Contact JOEL A MARCUS
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/17/1988
Decision Date 08/25/1988
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
Recalls CDRH Recalls
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